Quality Assurance Specialist
4 weeks ago
Scilex Holding Company is seeking a highly skilled Quality Control Consultant to support the development and commercialization of non-opioid pain management products. The ideal candidate will have a strong background in analytical development and quality control/analytical testing of commercial or late-stage clinical small molecule or biological products.
Key Responsibilities- Support analytical development and quality control/analytical testing of commercial or late-stage clinical small molecule products, drug substance, raw materials, packaging components, manufacturing equipment qualifications at existing CDMO/CMO or method a new CDMO/CMO.
- Review/support CDMO/CMO manufacturing services agreements, support quality agreements, RFP from analytical testing perspectives.
- Support testing for analytical method development and method validation/MV for commercial and clinical products at CMO/CDMO.
- Support testing for FMEA, process performance qualification/PPQ, continuous process verification/CPV, equipment qualification, site registration, cleaning studies/validation, shipping studies/validation, etc. for commercial and clinical products at CMO/CDMO.
- Author/review/approve from analytical testing perspectives of analytical method development, method validation protocols/reports, PV/PPQ, CPV, MBRs and EBRs and final product disposition, any CMC development protocols/reports, qualification/validation protocols/reports, stability protocols/data/reports, and release/stability analytical method development, method validation and testing for drug substances present in commercial and clinical products at CMO/CDMO.
- Ensure GMP compliance from analytical testing perspectives for raw materials and packaging components required for manufacturing of drug substances and commercial and clinical products.
- Minimum bachelor's degree in analytical chemistry, biochemistry, biology, chemical sciences or in a relevant scientific discipline or equivalent.
- Minimum of 8 to 12 + years of analytical development and quality control for Commercial Products or Late-Stage, Phase 3 Clinical Product in Pharmaceutical or Biologic Companies.
- Experience in Quality Control/Analytical Testing for GMP manufacturing of commercial products and/or late stage/Phase 3 clinical pipeline is a must.
- Experience in analytical method development, method qualification/method validation, release and stability testing, investigations, deviations, change controls, CAPA and OOS/OOT for commercial products and clinical pipeline is a must.
Scilex Holding Company offers a competitive salary and benefits package, as well as opportunities for professional growth and development.
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Quality Assurance Specialist
3 weeks ago
Palo Alto, California, United States Scilex Holding Full timeJob Title: Quality Assurance SpecialistAbout the Role:We are seeking a highly skilled Quality Assurance Specialist to join our team at Scilex Holding Company. As a Quality Assurance Specialist, you will be responsible for ensuring the quality and compliance of our pharmaceutical products.Key Responsibilities:- Support analytical development and quality...
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Quality Assurance Director
4 weeks ago
Palo Alto, California, United States I Peace, Inc.| Cell and Gene Therapy Manufacturing, cGMP iPSCs | Full timeQuality Assurance DirectorWe are a company that manufactures and sells GMP iPS cells products. Our goal is to provide high-quality products that meet regulatory requirements.We are seeking a Quality Assurance Director who can manage our internal Quality Management System and guide it in the right direction. The ideal candidate will have experience in Quality...
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Quality Assurance Director
3 weeks ago
Palo Alto, California, United States I Peace, Inc.| Cell and Gene Therapy Manufacturing, cGMP iPSCs | Full timeWe are a company that manufactures and sells GMP iPS cells products. Our goal is to provide high-quality products that meet regulatory requirements.We are currently looking for a candidate with the following skills:Knowledge of GMP and ability to manage the internal Quality Management System.Ability to accurately understand our internal products and...
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Palo Alto, California, United States Kohler Full timeJob Title: Quality Assurance Lead for Software and RegulatoryJob Summary:Kohler Ventures is seeking a Quality Assurance Lead to join our team in Palo Alto, CA. The successful candidate will be responsible for ensuring the quality and regulatory compliance of our software and hardware products in the health and wellness space.Key Responsibilities:Actively...
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Senior Software Quality Assurance Engineer
4 weeks ago
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Palo Alto, California, United States Kohler Full timeJob Summary:Kohler Ventures is seeking a Quality Assurance Lead to join our team in Palo Alto, CA. As a Quality Assurance Lead, you will be responsible for ensuring the quality and regulatory compliance of our software and hardware products in the health and wellness space.Key Responsibilities:Actively contribute to all aspects of Software Quality Assurance...
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Software Quality Assurance Engineer
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Palo Alto, California, United States Rivian Full timeAbout RivianRivian is a pioneering company that's revolutionizing the automotive industry with its innovative electric adventure vehicles. We're on a mission to keep the world adventurous forever, and we're seeking talented individuals to join our team.Role SummaryIn this exciting role, you'll be part of Rivian's Future Programs group, working on the...
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Software Quality Assurance Engineer
4 weeks ago
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Palo Alto, California, United States Kohler Co. Full timeJob Title: QA Lead Software and RegulatoryAt Kohler Co., we are seeking a highly skilled QA Lead to join our team in Palo Alto, CA. As a key member of our software development team, you will be responsible for ensuring the quality and regulatory compliance of our software products.Key Responsibilities:Contribute to all aspects of software quality assurance...
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Palo Alto, California, United States Rivian Full timeAbout RivianRivian is a pioneering company dedicated to creating a more adventurous and sustainable future. Our mission is to design and manufacture electric vehicles that not only reduce carbon emissions but also provide an unparalleled driving experience.Role SummaryWe are seeking a highly skilled Senior Quality Assurance Automation Engineer, Infotainment...
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AI Quality Assurance Engineer
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Radiology Imaging Specialist
3 weeks ago
Palo Alto, California, United States Nitelines USA, Inc Full timeJob Summary:We are seeking a skilled Radiology Imaging Specialist to join our team at Nitelines USA, Inc. The ideal candidate will have a strong background in radiology and be able to perform a variety of imaging procedures with precision and accuracy.Key Responsibilities: Perform all procedures in sub-specialized radiology areas, including evaluation of...
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Automation Software Quality Assurance Engineer
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Palo Alto, California, United States HexaQuEST Global, Inc. Full timeJob Overview:As a key member of our team at HexaQuEST Global, Inc., you will collaborate closely with our product team to define and implement data pipelines using Python and Scala. Your expertise in writing test cases and automation scripts will be instrumental in ensuring the quality and reliability of our data-driven solutions. Additionally, you will work...
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Laboratory Specialist
4 weeks ago
Palo Alto, California, United States Sutter Health Full timeJob SummaryWe are seeking a highly skilled Laboratory Specialist to join our team at Sutter Health. As a key member of our laboratory team, you will be responsible for integrating knowledge, theory, and practice to execute procedures in assigned areas of the laboratory.Key ResponsibilitiesPerform pre-analytic, analytic, and post-analytic procedures on...
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Senior Chemist
4 weeks ago
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Laboratory Specialist II
3 weeks ago
Palo Alto, California, United States Sutter Health Full timeJob Summary:As a Laboratory Specialist II at Sutter Health, you will play a vital role in ensuring the accuracy and reliability of laboratory results. Your primary responsibility will be to integrate knowledge, theory, and practice to execute procedures in assigned areas of the laboratory. This includes maintaining competence in all practices to perform...
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Clinical Laboratory Specialist
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Palo Alto, California, United States Sutter Health Full timeJob SummaryWe are seeking a highly skilled and experienced Pathologist Assistant II to join our team at Sutter Health. This is a full-time position that requires a strong background in laboratory operations, quality assurance, and surgical pathology.Key ResponsibilitiesIntegrate knowledge, theory, and practice to execute procedures in assigned areas of the...
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Senior Software Quality Engineer
4 weeks ago
Palo Alto, California, United States Guardant Health Full timeJob DescriptionGuardant Health is a leading precision oncology company focused on helping conquer cancer globally through the use of its proprietary tests, vast data sets, and advanced analytics. The company's oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes, and lower healthcare costs across all stages...