Quality Assurance Specialist
5 days ago
Bionova, a subsidiary of Asahi Kasei Medical, is seeking a Quality Assurance Compliance Specialist to join our team. As a rapidly growing biologics CDMO, we are committed to developing and manufacturing recombinant protein products using mammalian cell culture processes.
Key Responsibilities- Ensure products and processes meet established quality standards and regulatory requirements.
- Conduct audits, implement quality control procedures, and collaborate with cross-functional teams to enhance product quality and compliance.
- Provide training, support, and guidance to staff on quality standards and procedures.
- Drive continuous improvement and ensure Bionova's processes are compliant and inspection ready.
- Review and approve SOPs to ensure compliance with applicable regulations.
- Support Supplier Quality Management qualification activities.
- Monitor and analyze quality metrics and KPIs to identify trends and areas for improvement.
- Act as a subject matter expert on quality-related matters.
- Bachelor's or higher degree in life sciences, engineering, or related field.
- 3-5 years of experience working in a GMP environment with direct work on manufacturing, quality, process development, and/or quality control experience in biotechnology or pharmaceutical industries.
- Working knowledge of cGMP regulations and guidance.
- Competitive compensation package.
- Health benefits at a subsidized rate.
- Life insurance and disability program.
- Retirement plan (401K) with up to 8% employer match.
- Paid time off and holidays.
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Quality Assurance Specialist
9 hours ago
Fremont, California, United States Tek Support Full timeQuality Assurance SpecialistWe are seeking an experienced Quality Assurance Specialist to join our team at Tek Support in Alameda, CA. The ideal candidate will play a key role in ensuring product quality and compliance with regulatory requirements in the medical device industry.Responsibilities:Regulatory Compliance: Ensure compliance with FDA, ISO 13485,...
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Quality Assurance Specialist
4 weeks ago
Fremont, California, United States Hyve Solutions Full timeHyve Solutions is a leading provider of innovative technology solutions dedicated to supporting customers, business partners, and employees in achieving shared goals.Job Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for conducting inspections, performing...
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Quality Assurance Specialist
3 weeks ago
Fremont, California, United States Abbott Full timeAbout the RoleThis is an exciting opportunity to join Abbott's Diabetes Care division as a Quality Assurance Specialist. As a key member of our team, you will play a critical role in ensuring the quality and compliance of our products and processes.Key ResponsibilitiesLead and support internal and external audits to maintain compliance with regulatory...
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Quality Assurance Specialist
2 weeks ago
Fremont, California, United States QAPEL MEDICAL INC Full timeJob Title: Quality Systems SpecialistWe are seeking a highly motivated and detail-oriented Quality Systems Specialist to join our team at Q'Apel Medical Inc. This role will play a critical part in ensuring the quality and compliance of our medical devices.Key Responsibilities:Process Engineering Change Notices (ECOs) and other Quality Management System...
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Quality Assurance Specialist
2 weeks ago
Fremont, California, United States Supernal Full timeAbout SupernalSupernal is an Advanced Air Mobility company that's pushing the boundaries of human possibility. We're developing an electric vertical take-off and landing (eVTOL) vehicle and the ground-to-air ecosystem to support the emerging industry.Job SummaryWe're seeking a Senior Quality Engineer to join our dynamic team. As a key member of our Quality...
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Quality Assurance Specialist
2 weeks ago
Fremont, California, United States Supernal Full timeAbout the RoleWe are seeking a highly skilled Senior Quality Engineer to join our team at Supernal. As a key member of our Quality Assurance organization, you will play a critical role in ensuring the quality and reliability of our products and processes.Key ResponsibilitiesDevelop and implement quality plans, inspection and test methods, and procedures to...
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Quality Assurance Specialist
2 weeks ago
Fremont, California, United States Supernal Full timeAbout the RoleWe are seeking a highly skilled Senior Quality Engineer to join our team at Supernal. As a key member of our Quality Assurance organization, you will play a critical role in ensuring the quality and reliability of our products and processes.Key ResponsibilitiesDevelop and implement quality plans, inspection and test methods, and procedures to...
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Senior Quality Assurance Specialist
5 days ago
Fremont, California, United States Info Way Solutions Full timeSr. Quality Assurance Analyst Job DescriptionWe are seeking a highly skilled Sr. Quality Assurance Analyst to join our team at Info Way Solutions, LLC. As a key member of our quality assurance team, you will be responsible for ensuring the highest quality of our software products.Key Responsibilities:Develop and implement test strategies, test metrics, and...
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Senior Quality Assurance Specialist
2 weeks ago
Fremont, California, United States Info Way Solutions Full timeSr. Quality Assurance Analyst Job DescriptionInfo Way Solutions is seeking a highly skilled Sr. Quality Assurance Analyst to join our team. As a key member of our quality assurance team, you will be responsible for developing and implementing software test strategies, plans, and processes to ensure the delivery of production-ready code.Key...
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Surveillance Quality Assurance Specialist
2 weeks ago
Fremont, California, United States Info Way Solutions Full timeJob Title: Surveillance Quality Assurance AnalystInfo Way Solutions is seeking a highly skilled Surveillance Quality Assurance Analyst to join our team.Responsibilities:Conduct daily reviews of data in ESSENCE-FL from state and regional perspectives.Provide consultation and training on the system to county health department and state level users.Perform...
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Fremont, California, United States Neuralink Full timeJob SummaryWe are seeking a highly skilled Internal Audit Lead, Quality Assurance Specialist to join our Quality Team at Neuralink. As a key member of our team, you will be responsible for ensuring compliance with relevant regulatory standards and driving process improvements to enhance systemic compliance and quality standards.Key ResponsibilitiesConduct...
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Surveillance Quality Assurance Specialist
3 weeks ago
Fremont, California, United States Info Way Solutions Full timeJob SummaryInfo Way Solutions is seeking a highly skilled Surveillance Quality Assurance Analyst to join our team. As a Surveillance Quality Assurance Analyst, you will be responsible for conducting daily reviews of data in ESSENCE-FL from state and regional perspectives, providing consultation and training on the system to county health department and state...
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Quality Assurance Inspector
2 days ago
Fremont, California, United States Vishay Intertechnology Inc Full timeJob Title: Quality Assurance InspectorVishay Intertechnology Inc is seeking a Quality Assurance Inspector to join our team in Fremont, CA.Job Summary:We are looking for a detail-oriented and organized Quality Assurance Inspector to perform in-process and final visual inspections of ceramic substrates using stereo zoom and high-power microscopes. The ideal...
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Quality Assurance Supervisor
4 weeks ago
Fremont, California, United States Millennium Metalcraft, Inc Full timeQuality Assurance Supervisor at Millennium Metalcraft, Inc.Millennium Metalcraft, Inc. stands as a leading entity in the sheet metal and machining manufacturing sector. We are in search of a proficient Quality Assurance Supervisor to enhance our team. This role presents a remarkable opportunity for those looking to elevate their career within a thriving...
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Quality Assurance Intern
1 week ago
Fremont, California, United States Thermo Fisher Scientific Full timeQuality Assurance Internship OpportunityThermo Fisher Scientific is seeking highly motivated and detail-oriented individuals to join our team as Quality Assurance Interns. As a Quality Assurance Intern, you will have the opportunity to work on various projects that impact the quality of our products and services.Responsibilities:Partner with leadership to...
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Quality Assurance Manager
6 days ago
Fremont, California, United States PSG Global Solutions Careers Full timeJob Title: QA Interim ManagerAt PSG Global Solutions Careers, we're seeking a highly skilled QA Interim Manager to join our team. As a key member of our Quality Assurance group, you will play a critical role in ensuring the highest standards of quality in our pharmaceutical and medical products.Job SummaryWe're looking for a seasoned QA professional with...
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Quality Assurance Batch Record Specialist
1 month ago
Fremont, California, United States Astrix Full timeCompany Overview:Astrix is a leading global pharmaceutical organization dedicated to advancing treatment options for challenging diseases and conditions. We are currently seeking a skilled Batch Record Reviewer II to enhance our Quality Assurance team. This role presents a unique opportunity to contribute to innovative therapies and positively impact patient...
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Quality Assurance Batch Record Specialist
1 month ago
Fremont, California, United States Astrix Full timeCompany Overview:Astrix is a leading global pharmaceutical organization dedicated to developing innovative treatment solutions for unmet medical needs. We are currently seeking a skilled Batch Record Reviewer II to enhance our Quality Assurance team. This position offers a unique opportunity to contribute to pioneering therapies and positively impact patient...
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Fremont, California, United States Elma Electronic Full timeCompany OverviewElma Electronic Inc. stands at the forefront of the embedded computing industry, recognized globally for our innovative solutions. Our offerings encompass a range of modular components, including precision hardware, rotary switches, and embedded computing boards.With a worldwide presence, we maintain close relationships with our clients and...
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Quality Assurance Inspector
4 hours ago
Fremont, California, United States Vishay Intertechnology Inc Full timeJob Title: Quality Assurance InspectorVishay Intertechnology Inc is seeking a Quality Assurance Inspector to join our team. As a Quality Assurance Inspector, you will be responsible for performing in-process and final visual inspections of raw, metalized, and patterned ceramic substrates using stereo zoom and high-power microscopes, micrometers, calipers,...