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About Us At BikesOnline, our mission and purpose of "Ride More, For Less" is born from our belief that cycling has the power to improve lives, and the environment. We love to break through old norms, to get bikes and products to our customers quickly and to have a laugh while we do it. Founded in 2011, we’re global in our approach and presence with staff in 6 countries and growing. We have a genuine focus on nurturing our team with perks like flexible work arrangements, generous staff discounts, a commitment to ongoing learning and internal career progression across our international footprint. We are passionate cyclists who love inspiring others to ride more. We design our products, provide expert advice and support initiatives to encourage people from all walks of life to enjoy more cycling adventures. We are committed to delighting customers by sourcing and making quality products for less and providing a simplified and exceptional experience. What You'll Do The Quality Control Manager at BikesOnline is a linchpin role ensuring that every bicycle and accessory—from high-performance eBikes to entry-level commuters—meets the rigorous expectations of our global customer base. Reporting directly to the Co-CEO, you will bridge the gap between production and the customer experience, overseeing the lifecycle of a product from range planning, concept creation to floor to final assembly. This is a global role requiring a unique blend of market insights, technical engineering knowledge, supply chain diplomacy, a deep passion for the cycling industry, and strategic thinking to minimize warranty issues and optimize assembly efficiency. This role is critical in bridging the gap between our international manufacturing partners and our internal teams in Australia and the United States. Responsibilities include, but are not limited to: Quality Control & Compliance ProBuild Stewardship: Cultivate and maintain high-level relationships with suppliers to oversee the ProBuild (Assembly) process. This includes the training and auditing of key factory personnel in country. Regulatory Leadership: Maintain an expert-level understanding of import regulations, safety standards, and testing requirements across all operating markets (AU/US). Design & Improvement: Proactively recommend and implement design improvements based on customer feedback and market intelligence. Accountability: Hold suppliers accountable for uncompleted or substandard ProBuild work, including the management of credits and financial reconciliations. eBike Specialization: Lead quality control and compliance for batteries, eBikes, and chargers, ensuring all certifications meet jurisdictional legal requirements. Supply Chain Liaison: Manage the Insera supply chain coordinator person, based in Indonesia, to streamline communications and bridge operational gaps between companies. Packaging & Damage Mitigation Structural Design: Develop and refine packaging solutions with suppliers to ensure safe transit and ease of assembly for the end user. Strategic Analysis: Identify warranty trends related to shipping and packaging; develop strategic resolutions and communicate these expectations to global suppliers. Special Make-Up Units (SMUs) & Product Development Market Alignment: Partner with the Category Management Team to identify trends and assess market demand for SMU products. Concept to Production: Oversee the full lifecycle of SMUs with partner factories, including component selection, specification finalization, and performance compatibility. eBike Innovation: Prioritize the development of eBike models in collaboration with the Insera eBike team. Warranty & Technical Oversight Supplier Liaison: Act as the primary technical point of contact for global suppliers regarding warranty claims and defects in the US and AU markets. Team Leadership: Provide technical guidance to Warranty Leaders in the US and AU, ensuring efficient claim processing. Reporting: Generate and analyze monthly warranty reports to identify failure trends and drive systemic improvements. Operations & Systems Management Parts Sourcing: Support the parts ordering process, including sourcing and inventory management. Systems Optimization: Take ownership of the Brightpearl and OFX workflows within the sourcing process (liaising with Asana) to improve efficiency where existing processes are currently manual or fragmented. OEM Management: Review and authorize final placement for all OEM orders. Customer Education & Content Collaboration Assembly Technical Specs: Define the necessary tools and educational requirements for customer self-assembly. Content Partnership: Work with the Content/Marketing teams (led by Content) to translate technical manuals into user-friendly video formats and digital guides across a broad range of models. Global Reach: Periodic travel to Asia (factories/suppliers) and Europe (trade shows/vendors), with cross-office travel between the AU and US hubs. Time Zone Commitment: Must be available for a weekly standing meeting aligned with Indonesian time zones (WIB/WITA). About You Qualifications: Tertiary qualification in commerce, marketing, or business. Recognized certification in bicycle maintenance. Experience (Preferred) Extensive background and technical knowledge of bicycles, high-end components, and e-mobility systems (eBikes, batteries, and motors). In-depth knowledge of the global bicycle industry, including current market trends, manufacturing processes, and supplier dynamics. Proven experience training factory personnel and workshop staff in production standards, assembly methods, and ProBuild protocols. A track record of resolving complex customer complaints and technical warranty issues with effective, long-term solutions. Experience managing international vendor relationships and holding suppliers accountable for quality standards and financial credits. Hands-on experience ensuring products meet international standards, import regulations, and eBike certifications for AU and US markets. Proficiency in Google Workspace and experience working within ERP and Project Management environments. A deep personal enthusiasm for cycling with firsthand knowledge of current product trends and the end-user experience. Skills (Preferred) High-level mechanical proficiency with a "customer-first" mindset regarding ease of assembly and product reliability. Ability to navigate and optimize specialized tools including Brightpearl, OFX, and Asana to improve operational efficiency. An analytical and data-driven mindset comfortable using warranty reports and shipping trend data to drive strategic design and packaging changes. Exceptional verbal and written communication skills, with the specific ability to work effectively across different cultures, languages, and time zones. Strong ability to lead, mentor, and provide technical guidance to regional warranty teams and international supplier partners. A proactive, independent thinker who can identify potential issues in the supply chain before they impact the customer. Highly detail-oriented with the ability to prioritize and manage high-pressure tasks and global travel schedules simultaneously. What We Believe In Our company values are integral to our culture and success. We expect that you embrace our core values, with behaviors and actions that: Delight the Customer Focus on the Process Take responsibility Learn Grow and Develop One Team Together Why You’ll Love Working Here When you embark on your journey with BikesOnline, you’re not only joining a close-knit community, but contributing to a dynamic and rapidly expanding industry - sparking newfound creativity and innovation. We both welcome and value employee perspectives, as inclusivity and collective contribution are the foundations of our culture. If you’re passionate about bikes, that’s amazing! However, if not, our wealth of knowledge will allow you to absorb new skills. From personal development to career opportunities - we invest in our people and culture, providing a safe, trustworthy, and flexible work environment. We encourage you to be inquisitive, be yourself, and join the BikesOnline family! How To Apply? If this sounds like you, there’s no better time to join a team already full of awesome humans. Please include a cover letter outlining your interest in BikeOnline and a resume with your application. We will be in touch with you soon after you submit your application, as long as you have: Submitted a resume and cover letter. Working rights in the United States. Availability to attend regular meetings aligned with Indonesian time zones (WIB/WITA) Ability to undertake periodic international travel (Asia/Europe/AUS) as required BikesOnline is committed to creating a diverse environment and is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability or age.
About the Role: The Controller in a Medical Device Manufacturing company plays a critical role in overseeing the financial health and integrity of the organization. This position is responsible for managing all accounting operations, ensuring compliance with regulatory standards specific to the medical device industry, and providing accurate financial reporting to support strategic decision-making. The Controller will lead budgeting, forecasting, and financial analysis efforts to optimize operational efficiency and profitability. They will collaborate closely with cross-functional teams including manufacturing, quality assurance, and regulatory affairs to align financial goals with business objectives. Ultimately, the Controller ensures that the company maintains strong financial controls and transparency while supporting sustainable growth in a highly regulated environment. Minimum Qualifications: Bachelor’s degree in Accounting, Finance, or a related field. CPA certification or equivalent professional accounting qualification. Minimum of 7 years of progressive accounting experience, including at least 3 years in a controller or senior accounting role. Experience working within the medical device manufacturing industry or a similarly regulated environment. Strong knowledge of GAAP, and FDA regulatory requirements related to financial reporting. Experience with Microsoft NAV 365 Business Central Preferred Qualifications: Master’s degree in Accounting, Finance, or Business Administration. Experience with ERP systems commonly used in manufacturing such as SAP, Oracle, or Microsoft Dynamics. Familiarity with cost accounting and inventory management specific to medical device production. Proven track record of leading successful audits and implementing process improvements. Strong leadership experience managing accounting teams in a fast-paced, regulated environment. Responsibilities: Manage and oversee all daily accounting operations including accounts payable, accounts receivable, general ledger, and payroll. Prepare timely and accurate monthly, quarterly, and annual financial statements in accordance with GAAP and industry-specific regulations. Lead the budgeting and forecasting processes, working closely with department heads to develop financial plans that support business objectives. Ensure compliance with FDA regulations, and other relevant financial and operational controls specific to medical device manufacturing. Coordinate and support external audits and tax filings, maintaining strong relationships with auditors and regulatory agencies. Analyze financial data to identify trends, risks, and opportunities, providing actionable insights to senior management. Implement and maintain internal controls to safeguard company assets and ensure accuracy of financial information. Supervise and mentor accounting staff, fostering a culture of continuous improvement and professional development. Skills: The Controller will utilize advanced accounting and financial analysis skills daily to ensure accurate and compliant financial reporting. Strong leadership and communication skills are essential for managing the accounting team and collaborating with cross-functional departments. Expertise in regulatory compliance and internal controls will be applied to maintain the integrity of financial data and support audit processes. Proficiency with ERP and financial software enables efficient management of complex manufacturing cost structures and inventory accounting. Analytical skills are critical for interpreting financial trends and providing strategic recommendations that drive business performance and regulatory adherence.
The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the team: The Advanced Process Engineering team is responsible for the development of processes and manufacturing systems for next-generation products at Dexcom. We are building a world-class global R&D capability to support our future innovation, while helping champion the accessibility of sensing technologies. This role offers an individual the opportunity to lead with purpose and empathy by breaking down barriers to create a connected, compassionate world. As a Senior Manager of R&D Process Engineering you will have an opportunity to: Lead the day-to-day execution of advanced process development for next-generation products. You will oversee a team driving integration and optimization of complex, prototype to high-volume processes from concept to design transfer . This role is critical to ensuring manufacturability, reliability, scalability, and regulatory compliance across Dexcom’s innovation pipeline. Where you come in: Technical Leadership: Oversee a team of engineers in early phase prototype systems process development . Development and Mentorship: Build and lead a high-performing team. Foster a culture of innovation, accountability, and technical excellence. Manufacturing Process Development: Architect and implement advanced process development, equipment, and fixtures for new products and technologies. Oversee design-to-manufacturing transfers and enable scalable production systems. Process Optimization and Integration: Own complex process flows to enhance performance, yield, and reliability. Drive structured problem-solving using DOE and statistical analysis tools to reduce cost and improve efficiency. Quality and Regulatory Compliance: Ensure robust documentation (pFMEA, control plans) and validation protocols. Maintain compliance with FDA 21 CFR 820, ISO 13485, ISO 14971, and EU MDR. Cross-Functional Collaboration: Partner with R&D, Quality, Operations, and Regulatory teams to align technical execution with business objectives . Represent process engineering in executive reviews and strategic initiatives. What makes you successful: You have an advanced degree in Mechanical, Biomedical, or Materials Engineering, with deep expertise in process development and integration. You bring proven experience in high volume electromechanical devices advanced process development with a track record of launching complex products production. Experience leading process engineering teams in innovative, high-volume manufacturing organizations is strongly preferred. You are fluent in Six Sigma, Lean manufacturing, and structured problem-solving methodologies, with hands-on experience in process validation and statistical analysis tools like JMP. You understand the full product lifecycle—from concept to commercialization—and navigate quality systems and frameworks including FDA QSR, ISO 13485, ISO 14971, and EU MDR with confidence. You communicate with clarity and executive presence, translating technical insights into actionable strategies for diverse stakeholders. You embrace change and lead with empathy—adapting to evolving needs, championing accessibility, and driving purpose-driven innovation. Strategic Mindset Demonstrates sound judgment and critical thinking in evaluating complex scenarios and making high-quality decisions. Leads change with agility—anticipates future needs, overcomes resistance, and drives alignment across teams. Development & Collaboration Coaches and mentors emerging engineers and leaders through stretch assignments, feedback, and delegation. Communicates with clarity and executive presence—tailoring messages to technical and non-technical audiences. Operational Excellence Solves complex problems with a structured, results-oriented approach; leads CAPA and risk mitigation with decisiveness. Drives cross-functional collaboration to align technical execution with business goals and regulatory requirements. Values & Culture Leads with integrity, empathy, and commitment—modeling emotional intelligence and responsible entrepreneurship. Champions Dexcom’s mission to create a connected, compassionate world through accessible sensing technologies. What you’ll get: A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community . A full and comprehensive benefits program. Growth opportunities on a global scale. Access to career development through in-house learning programs and/or qualified tuition reimbursement. An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Travel Required: 10% Experience and Education: Typically requires a Bachelor’s degree in a technical discipline with 13+ years of industry experience 5-8 years of previous people management experience Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at talentacquisition@dexcom.com. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at talentacquisition@dexcom.com. Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications. Salary: $149,000.00 - $248,300.00
General Atomics Aeronautical Systems, Inc. (GA-ASI), an affiliate of General Atomics, is a world leader in proven, reliable remotely piloted aircraft and tactical reconnaissance radars, as well as advanced high-resolution surveillance systems. Under general supervision, with some detailed instructions and intermittent review, working in a loud manufacturing environment with a variety of epoxy agents, this position performs repetitive or standard procedures and assists in the fabrication, curing, build-up and assembly of various types of composite materials where required information is readily available, methods and sequences have been pre-determined, and tooling is provided. Works with blueprints, templates, sample parts, process sheets and other authorized information. DUTIES AND RESPONSIBILITIES: Assist in the preparation of molds and forms. Mark and cut tape, woven material, honeycomb, adhesive and similar materials following templates, guides or specific dimensions and sequences. Route, drill, trim, and sand to blueprint dimensions and tolerances. Vacuum bag parts for room temperature cure. Assist in the lay-up of composite materials to mold. Fit and smooth successive layers of materials as necessary to secure build-up free from wrinkles, air pockets and voids following directions and instructions. Assemble Aircraft components using structural adhesives, rivets and threaded fasteners. Prepare surface and paint composite and metal components including bodywork, contour shaping and sanding. Apply spray application of epoxy paints, urethane and water-based epoxy coatings, using a high-volume low-pressure spray gun. Assist in the development of shop aids to facilitate fabrication, trimming and assembly as required. Check expiration dates of materials prior to use, prepare proper mixes of resins and catalysts. May monitor and verify quality in accordance with statistical process or other control procedures. Maintain records as required. Support quality process by maintaining work area in an orderly condition by returning tools, equipment and materials to storage area. Responsible for observing all laws, regulations and other applicable obligations wherever and whenever business is conducted on behalf of the Company. Expected to work in a safe manner in accordance with established operating procedures and practices. Additional Functions: Other duties as assigned or required. We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply. Job Qualifications Typically requires High School diploma or equivalent and two or more years of related experience. Must be able to verbally communicate, read and comprehend written and verbal instructions, detailed blueprints and other similar authorized drawings and documents, and be capable of doing simple mathematical calculations. Must be able to use hand tools, such as rollers, paper cutters, scissors, x-acto knives, electric heat gun and fixtures such as molds and mandrels. Ability to use measuring instruments such as scales and protractors and calipers. May require respirator certification. Must be able to work in a loud environment; work extended hours as required; and be able to lift assemblies weighing up to 50 lbs. Job Category Manufacturing Experience Level Entry-Level (0-2 years) Workstyle Onsite Full-Time/Part-Time Full-Time Hourly Pay Range Low 48,160 Pay Range High 71,598 Travel Percentage Required 0% - 25% Relocation Assistance Provided? No US Citizenship Required? Yes Clearance Required? No
Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com. A brief overview The Manager / Sr. Manager, Quality Control fulfills a critical role in the active pharmaceutical ingredient (API) manufacturing operations. This individual is responsible for managing and coordinating stability testing, raw material qualification, testing and release, and validation projects. The Manager / Sr. Manager coordinates both in-house and contract laboratory testing activities. Additionally, this individual supports the Director, Quality Control in reviewing data and reports. This role also serves to advance analytical capabilities and contributes to the development of the Quality Control department. What you will do Manage and oversee execution of QC testing including IPC, API, raw material, validation, release, EM and microbial testing Supervise QC Scientists. Provide training, day-to-day scheduling, mentoring, and coaching for QC personnel Establish and revise specifications and sampling plans for IPC, raw materials and final product Develop and optimize new and existing analytical methods for qualification and release testing Coordinate stability program and the testing to meet stability endpoints, as needed Manage IPC release activities, raw material and API release activities to meet deadlines tied to manufacturing schedules Write, review, and approve QC Standard Operating procedures (SOP’s) as needed Evaluate, recommend, and implement new analytical technologies and instrumentation for raw material, final product, In process, microbial, environmental, and water testing Investigate Out-Of-Specification (OOS) test results, write reports and implement corrective and preventive actions (CAPA) to prevent recurrences Manage external test laboratories for contract testing of raw materials and other related testing Review test data for completeness and accuracy Provide timely responses to internal and external inquiries Stay abreast of new developments in analytical technologies Contribute to improvements in laboratory operations to increase efficiency and GMP compliance Qualifications Bachelor's degree in a relevant scientific field with a minimum of 8 years’ industry experience Master's degree in a relevant scientific field with a minimum of 5 years’ industry experience (preferred) PhD in a relevant scientific field with a minimum of 2 years’ industry experience (preferred) 1-3 years’ management experience (preferred) 1-3 years’ experience in managing projects (preferred) Extensive experience in GMP laboratory testing such as IPC, HPLC, GC, TLC, UV-VIS Spectrophotometer, Karl Fisher Titrator, FTIR, MS, LAL, bioburden, etc. Thorough knowledge and understanding of analytical chemistry, including USP materials testing Creativity to solve technical and compliance problems Comply with good housekeeping and safety practices Experience in writing standard operating procedures (SOP’s) and test methods Excellent written and oral communication skills Excellent computer knowledge, including Microsoft Word, Excel, Power Point and Access Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one’s time Ability to drive projects to success under time constraints Communicate effectively and ability to function well in a team environment Base salary range: Manager: $109,396 - $164,095 Sr. Manager: $133,304 - $183,293 Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training. Total Rewards We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days. Corporate Social Responsibility Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem. Bachem Americas is an Equal Opportunity Employer As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status. Please note: unsolicited resumes from recruitment agencies will not be considered. Nearest Major Market: San Diego
*SUMMARY: *Perform floral quality inspections. Ensure product meets company quality specifications. Hours - 5:00am - 1:30pm (Availability to work OT on weekdays and weekends) Work Schedule: Monday - Friday (Subject to Change) Approximate dates of Assignment: 04/15/2026 - 05/04/2026 (Subject to change) 04/20/2026 - 05/04/2026 (Subject to Change) *ESSENTIAL DUTIES AND RESPONSIBILITIES include*: Other duties may be assigned. * Verify bouquet/arrangement is made according to recipe specifications. * Ensure bouquet wrap and plant food are placed correctly. * Verify bouquets are being cut the same length. * Audit daily production table statistics for accuracy. * Ensure UPC labels contain the correct code, pricing and production date and pull date. * Ensure correct numbers of stems are being used. * Print daily PO arrivals * Being able to find and select boxes to check * Make inspections * UPC information * Standard compliance * Assortment * Make reports * Water testing * Critical age inventory * Check of temperatures and pH * Notify Quality Control Manager/Production Supervisor regarding any issues concerning quality. * *QUALIFICATIONS* * to perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. * Ability to work on weekends and holidays (peak season's). * Ability to work in a refrigerated environment. * Ability to lift up to 50 lbs. (heavy lifting) * Ability to follow directions. * Ability to communicate effectively in English and Spanish. * Ability to work effectively and relate well with others. * Basic computer skills. *EDUCATION and/or EXPERIENCE* Minimum one -year experience in the floral industry training. High School or GED preferred. *LANGUAGE SKILLS* Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in on-on-one and small group situations to customers, clients, and other employees of the organization. Ability to converse in English and Spanish. *MATHEMATICAL SKILLS* Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. *REASONING ABILITY* Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions. Ability to deal with problems involving a few concrete variables in standardized situations. *PHYSICAL DEMANDS* The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is required to frequently stand, walk, use hands to finger, handle, or feel and talk or hear, and to reach with hands and arms. The employee must frequently lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. *WORK ENVIRONMENT* The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly exposed to extreme cold, wet and humid conditions (non-weather). The noise level in the work environment is usually moderate. Copy and paste the link below and apply directly to our career center for the Quality Control position: https://workforcenow.adp.com/mascsr/default/mdf/recruitment/recruitment.html?cid=3ca6dfee-a9c1-4e24-a942-a8e3179da5e4&ccId=9201070367831_2&lang=en_US Job Type: Temporary Pay: From $18.50 per hour Work Location: In person
At ACON labs, we are making a difference in medical care by offering medical devices for diagnosing a variety of conditions. In addition, we are able to streamline and reduce costs for the physician and/or patient directly. Come join us in developing the latest technologies that enhance human life and be a part of our growing, dynamic company. We are seeking a Senior Quality Assurance Engineer to join our team. As a Senior Quality Engineer, you will manage and lead operations and continuous improvements of the company’s CAPAs, NCMR/Deviations and Supplier Management programs to ensure the best practices and compliance with federal and global regulatory requirements. *Essential Duties and Responsibilities (includes but not limited to):* CAPA Program * Manage the company’s CAPA processes with focus on driving improvements in products and process performance. · Coordinates and support activities for root cause investigations, and implementation of corrections and corrective actions, as well as evaluation of effectiveness of implemented changes. · Facilitate cross functional team discussions in support of CAPA investigations and risk impact assessment report documents as per defined timelines. * Monitor CAPA KPIs, perform analysis, and interpret trends for process/product quality improvements. * Provide training and coaching to employees authoring, reviewing, and approving CAPAs. * Provide subject matter expertise on CAPA activities to the overall site. * Establish and maintain expert knowledge on quality system CAPA regulatory requirements in accordance with applicable FDA Regulations (21 CFR: Parts 820), and ICH Guidance, as well as other applicable regulatory requirements applicable to the organization. Manufacturing Deviations, NCMRs, and Variances: · Manage the process for issuing and evaluating Manufacturing Deviations and support resolution, as required. · Manage the process for issuing and evaluating Non-Conformance records (NCMR’s) and support resolution of Quality issues. · Manage the process for issuing and evaluating Variance reports for QMS processes and support resolution, as required. Other: · Participate in company’s Internal Audit program. · Act as SME for CAPAs, Manufacturing Deviations, NCMRs, and Variances during Regulatory and Customers audits. · Supports Management review by providing data and KPIs related to essential duties. · Maintains Lot number database and provides part numbers and lot numbers as requested. · Reviews/Scans upstream DHRs and creates COCs upon approval. · Other duties may be assigned *Supervisory Responsibilities* · May oversee and mentor junior staff *Education and/or Experience* · Bachelor’s degree in life science or engineering, or equivalent focus of study from an accredited university or college with 5-8 plus years relevant experience or master’s degree with 3-5 plus years of relevant experience. *Required Knowledge, Skills and Abilities* · Proficient knowledge of Quality Engineering policies, principles and best practices including quality standards: ISO 13485, 21CFR Part 820, ISO 14971, and other appropriate industry standards. · Strong team player. · Must be well organized, detail-oriented and able to maintain precise records. · Ability to multi-task, prioritize and manage time effectively, while maintaining quality. · Must have strong oral and written communication skills and computer skills. · Successful history of working independently with minimal supervision. · Strong interpersonal skills with reputation for collaboration with colleagues · Strong computer skills including MS Office (Word, Excel, PowerPoint, MS Project) The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At ACON it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $81,000 -$95,000. ACON offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and ACON may amend, terminate, or enhance the benefits provided, as it deems appropriate. Job Type: Full-time Pay: $81,000.00 - $95,000.00 per year Benefits: * 401(k) * 401(k) matching * Dental insurance * Employee assistance program * Flexible spending account * Health insurance * Life insurance * Paid time off * Vision insurance Work Location: In person
We are currently recruiting for a Flexo Press Operator to join our Production Team! In this role, you will be responsible for setting up and operating the printing press to produce labels and related products. *_Responsibilities:_* · Reads job order and loads dies into press, installs print cylinder on shaft and installs print cylinder in press. · Fills ink pans, screens with prescribed inks. · Starts press, adjusting speed and alignment of stock to the print cylinder as necessary. · Engages print cylinders; adjusts printing impression as necessary, places print cylinders lead-to-lead and runs down approval strip. · Cuts sample of approval strip from printed roll, inspects for imperfections such as print to print out of register, print to die out of register, missing impression, making adjustments as necessary. · Cleans plates, print cylinders and dies as needed, performs daily, weekly and monthly maintenance as required. · Mixes inks to produce and maintain desired colors and viscosity. · Keeps work areas clear and organized; maintains housekeeping standards *_Qualifications:_* High school diploma or general education degree (GED); or one to three years related experience and/or training; or equivalent combination of education and experience A minimum of one year of flexographic printing press experience preferred Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals Must be able to read and interpret ruler, scales and other measurement devices. While performing the duties of this job, the employee is regularly required to stand and frequently is required to walk The employee must frequently lift and/or move up to 50 pounds with or without mechanical assistance Specific vision abilities required by this job include close vision, color vision, depth perception and ability to adjust focus Excellent 401(k) retirement plan with generous company contribution Job Type: Full-time Pay: $28.00 - $38.00 per hour Education: * High school or equivalent (Preferred) Work Location: In person
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. The Quality Control Senior Associate, Microbiology & Sample Management, is responsible for performing routine and non-routine Environmental Monitoring (EM), routine testing of incoming raw materials, product (in-process, release, and stability) in support of GMP manufacturing at Abzena. The Senior Associate will also be responsible for the receipt, control, and disposal of GMP samples submitted to the QC lab. Responsibilities Perform routine, non-routine environmental monitoring (EM) of the GMP manufacturing facilities for total particulates, air viables, and surface viables. Gown for and work in a cleanroom environment. Perform routine monitoring of pharmaceutical water systems. Perform routine monitoring of pharmaceutical gas systems. Perform bioburden and endotoxin testing. Initiate and participate in the investigations of EM excursions, deviations, and out of specifications. Assess any potential impact on product quality. Author and execute qualification/validation protocols. Author qualification/validation reports. Assist in trending EM data and generate quarterly reports and yearly reports. Performs stability set downs and pulls, Reference Standard pulls, and maintains documentation associated with stability pulls and Reference Standard/ sample traceability. Perform analysis of in-process samples, APIs, and stability samples using existing methods. Support assay transfer, qualification and validation activities for client’s specific methods. Receive, log, inventory, and transfer/distribute incoming Non-GMP (if applicable) and GMP samples into QC Sample Submission and appropriate laboratory. Maintain QC lab equipment and provide assistance, as needed, during equipment and facility qualification activities. Interact closely with other departments to ensure efficient, compliant and timely execution of project activities. Provide assistance as needed to maintain functioning QC Laboratory, including material ordering, inventory control, general housekeeping and other duties. Initiates purchase and shipment requests and outsource sample submission forms for outsource testing. Accurately and precisely document and record laboratory activities, results, and conclusions. Provides review of compendial testing data and associated documentation. Author and review Quality Control standard operating procedures (SOPs) Adhere to quality standards set by regulations and Abzena’s policies, procedures and mission. Communicate effectively with supervisors, colleagues and subordinates. Follow best practices related to the systems and processes that support the practices and documentation in the GMP facility for manufacturing clinical material Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results with a customer driven focus. Qualifications Minimum of a B.S degree in Microbiology or related discipline with 5 years of experience in environmental monitoring of GMP facilities. Minimum of three (5) years of experience working within a GMP Microbiology Lab. Knowledge of theoretical and practical aspects of analytical methods utilized in microbiology labs, including Bioburden, TOC, Endotoxin, Conductivity, Gram staining, and Microscopy. Experience with the transfer and qualification/ validation of large molecule focused methods. Experience with preparing test reports, qualification/validation protocols, and SOPs. Ability to gown and gain access to the cleanroom and utilities areas. Ability to author excursion reports, trend reports, qualification/ validation protocols, qualification/validation reports, CAPAs, and SOPs as needed. Demonstrate understanding of USP, EP, and FDA microbiology testing requirements Strong written and oral communication skills, proficient with Microsoft Office software Support Microbiology staff members as needed FLSA: Non-Exempt Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Predator Motorsports Inc. is the world leader in Hummer H1 Off-Road custom vehicle builds. We have been in business for over 21 years and are quickly expanding despite this dire economic environment. Predator Motorsports is considered an essential business and while adhering to the CDC’s Guidance pertaining to COVID-19 we have and will remain open during the California Stay at Home Orders. We have two locations, one in California and one in Florida. Our Vista, California location is looking for a Full-Time Fabricator to join our team. The ideal candidate for this position is a Welder/ Fabricator with a minimum of 3 years of fabrication experience in metal and automotive fixtures. They must be able to work both independently and as a team member to complete work assignments. *Basic knowledge of tube bending, Grinding ,Finishing & MIG welding proficiency is required.* *Job Description:* Fabricate off-road parts for hummer vehicles specializing in tig welding. Assemble and weld production parts *Duties include but are not limited to:* · Fabricator will be involved in metal handling, cleaning of parts, materials, and equipment. · Able to follow directions and tasks as specified by supervisor · Weld steel and aluminum components with welding equipment as specified by layouts, engineering drawings, work orders, or verbal instructions · Able to follow directions and tasks as specified by supervisor. · Weld steel and aluminum components with welding equipment as specified by layouts, engineering drawings, work orders, or verbal instructions. · Work includes set-up, laying out work using jigs/fixtures or hand layouts to fabricate parts and/or rework finished products. · Work with other employees to assist in the fabrication or welding of multi-component parts. · Operate hoists, hand power tools, grinders, cutting torch, and other hand tools related to the jobs needs. · Inspect and correct welds as necessary to meet product specifications. · Read, understand and follow job order specifications, engineering drawings, and/or work orders. *Desired Attributes:* · *Strong Attention to detail and a willingness to learn.* · Willingness to cross-train and perform the work of other job tasks in addition to the primary assigned position. · Reliability and a “team focused “attitude is a must. _*A Welding Test will be administered to determine experience level. If contacted for an interview, please bring your Welding Helmet and Gloves.*_ Due to the nature of our business, we have adopted a STRICT DRUG FREE policy. Candidates will be required to pass a drug test prior to employment. Please note that Full-Time benefits shall include, Medical (50% of Employee Cost paid by Employer),Dental, Vision and PTO. _****Schedule will be Four 10 Hr Days per week (6:30 AM-5:00 PM) Monday through Thursday.****_ If you feel that you meet the requirements, kindly reply with a cover letter and a copy of your resume. We are looking forward to hearing from you! _***** Please note that this position is direct hire only. No Recruiters, thank you.*****_' ' Work Location: * One location Work Remotely * No Job Type: Full-time Pay: $22.00 - $27.00 per hour Benefits: * Dental insurance * Health insurance * Life insurance * Paid time off * Vision insurance Experience: * Welding: 1 year (Required) Work Location: In person
*Location: San Clemente, CA* *Company: Modern Shelving* Modern Shelving, a growing small business specializing in modern storage and organization systems, is looking for a Production and Packaging Specialist to join our warehouse team in San Clemente, CA. About Modern Shelving We design and manufacture contemporary shelving and storage solutions for both residential and commercial customers. Our team is focused on quality, reliability, and excellent customer service, and we are expanding to meet increasing demand. Position Overview The Production and Packaging Specialist will support daily warehouse operations, including the preparation, assembly, and packaging of shelving components and related materials. Key Responsibilities * Assist with production and assembly of shelving unit components. * Perform light machining and cutting of aluminum components to specified measurements. * Inspect products to ensure quality and consistency. * Package finished products for shipment according to company standards. * Maintain a clean, safe, and organized work area. * Work with team members to meet production and shipping deadlines. Opportunities for Growth Modern Shelving supports employee development and internal advancement. As you gain experience, there may be opportunities to take on additional responsibilities in production, logistics, or warehouse coordination. Qualifications * Strong attention to detail. * Willingness to learn and work in a fast-paced environment. * Ability to follow written and verbal instructions. * Ability to work effectively as part of a team. * Previous warehouse, production, or manufacturing experience is helpful but not required. * Ability to regularly lift and move boxes or products weighing 50 pounds or more. * Reliable attendance and punctuality are essential. How to Apply Please email your resume and a brief cover letter describing your relevant skills and interest in the position to: *kristy@modernshelving.com* Modern Shelving is an equal opportunity employer. All qualified applicants are encouraged to apply. *Mandatory drug testing is required for all potential hires.* Versión en Español *Especialista en Producción y Empaque* Ubicación: San Clemente, CA Empresa: Modern Shelving Modern Shelving, un negocio pequeño en crecimiento especializado en sistemas modernos de almacenamiento y organización, busca un Especialista en Producción y Empaque para unirse a nuestro equipo de almacén en San Clemente, CA. Sobre Modern Shelving Diseñamos y fabricamos soluciones contemporáneas de estanterías y almacenamiento para clientes residenciales y comerciales. Nuestro equipo se enfoca en la calidad, la confiabilidad y el excelente servicio al cliente, y estamos ampliando nuestro equipo para cubrir la creciente demanda. Descripción del Puesto El Especialista en Producción y Empaque apoyará las operaciones diarias del almacén, incluyendo la preparación, ensamblaje y empaque de componentes de estanterías y materiales relacionados. Responsabilidades * Asistir en la producción y ensamblaje de componentes de unidades de estantería. * Realizar trabajos ligeros de maquinado y corte de componentes de aluminio según medidas especificadas. * Inspeccionar productos para asegurar su calidad y consistencia. * Empacar productos terminados para su envío conforme a los estándares de la empresa. * Mantener un área de trabajo limpia, segura y organizada. * Colaborar con los miembros del equipo para cumplir con los plazos de producción y envío. Oportunidades de Crecimiento Modern Shelving valora el desarrollo de sus empleados y ofrece oportunidades de crecimiento interno. A medida que adquieras experiencia, podrás asumir responsabilidades adicionales en producción, logística o coordinación de almacén. Calificaciones * Gran atención al detalle. * Disposición para aprender y trabajar en un entorno de ritmo rápido. * Capacidad para seguir instrucciones orales y escritas. * Capacidad para trabajar de manera efectiva en equipo. * Experiencia previa en almacén, producción o manufactura es un plus, pero no es indispensable. * Capacidad para levantar y mover cajas o productos de 50 libras (aprox. 23 kg) o más de forma regular. * Asistencia y puntualidad confiables. Cómo Aplicar Envía tu currículum y una breve carta de presentación describiendo tus habilidades relevantes y tu interés en el puesto a: *kristy@modernshelving.com* Modern Shelving es un empleador que ofrece igualdad de oportunidades. Animamos a candidatos de todos los orígenes a postularse. *Se requiere prueba de drogas obligatoria para todos los candidatos seleccionados.* نسخه به زبان فارسی *کارشناس تولید و بستهبندی* موقعیت: سن کلمنته، کالیفرنیا شرکت: Modern Shelving شرکت Modern Shelving، یک کسبوکار کوچک در حال رشد در زمینه طراحی و تولید سیستمهای مدرن قفسهبندی و نگهداری، به دنبال جذب یک کارشناس تولید و بستهبندی برای تیم انبار خود در سن کلمنته، کالیفرنیا است. درباره Modern Shelving ما راهحلهای مدرن قفسهبندی و ذخیرهسازی را برای خانهها و کسبوکارها طراحی و تولید میکنیم. تمرکز ما بر کیفیت، قابل اعتماد بودن محصولات و رضایت مشتری است و برای پاسخگویی به تقاضای رو به رشد، تیم خود را گسترش میدهیم. شرح موقعیت شغلی کارشناس تولید و بستهبندی از عملیات روزانه انبار پشتیبانی میکند، از جمله آمادهسازی، مونتاژ و بستهبندی قطعات قفسهها و سایر اجزا. مسئولیتها * کمک در تولید و مونتاژ قطعات واحدهای قفسهبندی. * انجام ماشینکاری سبک و برش قطعات آلومینیومی طبق اندازههای مشخص. * کنترل و اطمینان از کیفیت و یکنواختی محصولات. * بستهبندی محصولات نهایی برای ارسال مطابق با استانداردهای شرکت. * حفظ محیط کاری تمیز، ایمن و منظم. * همکاری با سایر اعضای تیم برای رسیدن به اهداف تولید و ارسال. فرصتهای رشد Modern Shelving از رشد شغلی کارکنان حمایت میکند و فرصت ارتقای داخلی را فراهم میسازد. با کسب تجربه، میتوانید مسئولیتهای بیشتری در بخش تولید، لجستیک یا هماهنگی انبار بر عهده بگیرید. شرایط مورد نیاز * دقت و توجه بالا به جزئیات. * تمایل به یادگیری و کار در محیط پرسرعت. * توانایی پیروی از دستورالعملهای شفاهی و کتبی. * توانایی کار گروهی مؤثر. * تجربه قبلی در انبار، تولید یا ساخت مزیت محسوب میشود، اما الزامی نیست. * توانایی بلند کردن و جابهجایی منظم جعبهها یا محصولاتی با وزن ۵۰ پوند (حدود ۲۳ کیلوگرم) یا بیشتر. * تعهد به حضور منظم و وقتشناسی. نحوه ارسال درخواست لطفاً رزومه خود و یک نامه کوتاه انگیزشی که مهارتهای مرتبط و علاقه شما به این موقعیت را توضیح میدهد، به آدرس زیر ایمیل کنید: *kristy@modernshelving.com* Modern Shelving یک کارفرمای دارای فرصت برابر برای همه متقاضیان است و از افراد با هر پیشینهای برای ارسال درخواست استقبال میکند. *انجام آزمایش مواد مخدر برای تمامی استخدامهای احتمالی الزامی است* Job Type: Full-time Pay: $17.00 - $22.00 per hour Benefits: * Paid time off * Professional development assistance Experience: * manufacturing: 1 year (Preferred) Language: * Spanish (Preferred) Location: * San Clemente, CA (Preferred) Work Location: In person
General Atomics Aeronautical Systems, Inc. (GA-ASI), an affiliate of General Atomics, is a world leader in proven, reliable remotely piloted aircraft and tactical reconnaissance radars, as well as advanced high-resolution surveillance systems. We have an exciting opportunity for a Second Shift Quality Inspector to join our Poway, CA team. This position is responsible for performing precise detailed inspections of aircraft, aircraft sub-assemblies, and systems using established inspection procedures, techniques and methods. Performs inspections on Line Replaceable Units (LRU’s), electrical/mechanical installations, composite assemblies, aircraft, and all additional duties needed to inspect, witness test, and maintain current configuration of units and tests. Ensures all measuring devices and test equipment are within calibration dates that conform to required standards. Responsible for tracking and ensuring that all items submitted for inspection or testing are at their latest release level. Maintains neat and legible inspection and test records as required. May perform duties as required in the assembly/disassembly inspection of components, assemblies or sub-assemblies. DUTIES AND RESPONSIBILITIES: Visually inspects aircraft and aircraft installation sub-assemblies. Performs in-process and final inspection or tests of aircraft, major components, subsystems and systems. Records test equipment calibration information and test data during system tests. Maintains proper records of these tests and inspections and configuration of systems under tests. Interfaces with customer representatives during inspections and tests of company products. Presents written inspection results, including configuration data when requested by the customer. Coordinates regularly with supervisory and engineering personnel. Notifies engineering of nonconforming characteristics and initiates written and verbal reports. Executes internal surveillance inspection and follow up. May assemble components, assemblies or sub-assemblies and perform other duties required in the assembly of equipment or units. May disassemble, modify, rework, reassemble and test experimental/prototype assemblies or assemblies according to specifications. May provide direction and guidance to less experienced staff. Maintains the strict confidentiality of sensitive information. Performs other duties as assigned. Responsible for observing all laws, regulations, and other applicable obligations wherever and whenever business is conducted on behalf of the Company. Expected to work in a safe manner in accordance with established operating procedures and practices. We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply. Job Qualifications Typically requires an associate's degree, trade school certificate, military training or equivalent in quality inspections or certification by a professional group such as ASQ or AWS, and one or more years of progressive experience in electrical, mechanical, electromechanical or metrology inspection and calibration. May substitute additional experience in lieu of formal education and training. Requires an extensive knowledge of inspection procedures, processes, devices and aids in a manufacturing environment as well as a wide and comprehensive knowledge of inspection concepts and principles including the ability to read and understand complex engineering drawings, specifications, procedures and manuals. Must possess: The ability to identify, analyze and interpret data. Strong interpersonal, verbal and written communication skills to explain detailed information effectively with all levels of employees including management and outside customers and vendors. Organization skills to maintain flow of work within the unit. The ability to establish priorities and maintain the confidentiality of sensitive information. Detailed knowledge of computer operations and applications and word processing and spreadsheets. The ability to work both independently and in a team environment is essential as is the ability to work extended hours required. FAA Airframe or Powerplant Certification, Inspection Authorization, past FAA designee experience or Military equivalent is preferred. Ability to obtain and maintain DoD Security clearance is required. Job Category Quality Experience Level Entry-Level (0-2 years) Workstyle Onsite Full-Time/Part-Time Full-Time Hourly Pay Range Low 52,020 Pay Range High 77,325 Travel Percentage Required 0% - 25% Relocation Assistance Provided? No US Citizenship Required? Yes Clearance Required? Desired Clearance Level Secret