- Batch record release
- CAPAs, deviations, and change control
- SOP revision experience
- QMS implemetation experience
- Bachelor's degree in Life Science or related field
- 3+ years of batch review experience
- Biologics GMP experience
- Highly preferred drug substance or drug product
- 5+ years of pharmaceutical/ biotechnology experience
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Quality Assurance Specialist
1 week ago
Actalent San Mateo, United States Full timeQuality Assurance Specialist · HYBRID role, onsite in Foster City, CA · Description: · ● Receives product complaints for products from the US and Canadian markets. · Documents in Quality System for investigation for product complaints and triages safety events to Pharmacovigilanc ...
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Quality Assurance Specialist
1 week ago
Actalent San Mateo, United States Full timeDescription: · ● Receives product complaints for products from the US and Canadian markets. · Documents in Quality System for investigation for product complaints and triages safety events to Pharmacovigilance Department. Performs or provides support for product complaint investi ...
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Quality Assurance Specialist
1 week ago
Actalent San Mateo, United States Full timeDescription: · 20% BRR · 80% Analytical focused · • Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements · • Serves as QA Lead for clinical and commercial projects. · • Leads quality investigations/deviations/ ...
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Quality Assurance Specialist
1 week ago
Actalent San Mateo, United States Full timeDescription: · ● Receives product complaints for Gilead products from the US and Canadian markets.Documents in Gilead Quality System for investigation for product complaints and triages safety events to Gilead Pharmacovigilance Department. Performs or provides support for product ...
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Quality Assurance Specialist
1 week ago
Actalent San Mateo, United States Full timeDescription: · ● Receives product complaints for products from the US and Canadian markets. · Documents in Quality System for investigation for product complaints and triages safety events to Pharmacovigilance Department. · Performs or provides support for product complaint inve ...
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Quality Assurance Specialist
4 days ago
Actalent San Mateo, United States Full timeDescription: · • Receives product quality complaints (typically via phone or fax or email), from healthcare professionals and patients · • Documents all incoming complaints in to complaint management system timely and notifies other QA specialists for start of investigations · • ...
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Quality Assurance Specialist
6 days ago
Actalent San Mateo, United States Full timeDescription: · Role and Responsibilities: · • Review and approve master batch records, labels, specifications and other pre-production documents for Clinical/Commercial Drug Product in compliance with FDA and international health agency requirements. · • Review executed productio ...
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Quality Assurance Specialist
1 week ago
Actalent San Mateo, United States Full timeDescription: · ● Receives product complaint from the US and Canadian markets. · Documents in Quality System for investigation for product complaints and triages safety events to the Pharmacovigilance Department. Performs or provides support for product complaint investigations · ...
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Senior Specialist, Quality Assurance
2 weeks ago
Allakos Inc Redwood City, United StatesSenior Specialist, Quality Assurance · Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases. · Allakos is committed to developing ...
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Senior Specialist, Quality Assurance
2 weeks ago
Allakos Inc Redwood City, United StatesSenior Specialist, Quality Assurance · Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases. · Allakos is committed to developing ...
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Quality Assurance Specialist II
2 days ago
Pulmonx Redwood City, United StatesPulmonx · is looking for a · Quality Assurance Specialist II · to join and our team Who is · Pulmonx ? We are the maker of the Zephyr Endobronchial Valve and a global leader in interventional pulmonology, planning tools, and treatments for obstructive lung disease. · Respons ...
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Quality Assurance Specialist II
2 days ago
Pulmonx Redwood City, United StatesPulmonx · is looking for a · Quality Assurance Specialist II · to join and our team Who is · Pulmonx ? We are the maker of the Zephyr Endobronchial Valve and a global leader in interventional pulmonology, planning tools, and treatments for obstructive lung disease. · Responsi ...
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Senior Quality Assurance Specialist
5 days ago
Avails Medical, Inc. Menlo Park, United StatesABOUT AVAILS: · Avails Medical, Inc., is a well-funded medical device start-up based in Menlo Park, California. We are a leader in the development of rapid, automated and fully electrical antibiotic susceptibility testing (AST) technologies with our products eQUANTTM and eASTTM p ...
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Senior Quality Assurance Specialist
3 days ago
Avails Medical Inc Menlo Park, United StatesABOUT AVAILS: · Avails Medical, Inc., is a well-funded medical device start-up based in Menlo Park, California. We are a leader in the development of rapid, automated and fully electrical antibiotic susceptibility testing (AST) technologies with our products eQUANT and eAST plat ...
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Senior Quality Assurance Compliance Specialist
2 weeks ago
Nevro Corp. Redwood City, CA, United StatesAbout Nevro: · Nevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. We are focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The comp ...
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Quality Assurance Specialist
2 days ago
CloudEagle Palo Alto, United States[Full Time] Quality Assurance Specialist / Customer Support (US) at (United States) | BEAMSTART Jobs · BEAMSTART · News · Jobs · Database · More · All · Full Time · Part Time · Contract · Internship · Volunteer · Candidates · Post New Job · Recruiters · Quality As ...
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Quality Assurance Specialist II
2 days ago
Gilead Sciences Foster City, United StatesQuality Assurance Specialist II page is loaded · Quality Assurance Specialist II · Apply · locations · United States - California - Foster City · time type · Full time · posted on · Posted 8 Days Ago · job requisition id · R · For Current Gilead Employees and Contracto ...
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Quality Assurance Specialist II
2 weeks ago
Gilead Sciences, Inc. Foster City, United States Full timeQuality Assurance Specialist II · United States - California - Foster City · Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investiga ...
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Quality Assurance Specialist II
2 days ago
Gilead Sciences Foster City, United States RegularJob Description · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therap ...
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Skyline Solutions Elizabeth Lake, CA, United States Freelance**What the company offers you**: · - Permanent employment · - Performance-based pay · - High vacation and leisure value · - Home office possible under certain conditions · - Recognized social benefits · - Flextime / Home office possible under certain conditions · - Company cantee ...
Quality Assurance Specialist - Redwood City, United States - EPM Scientific
Description
We are currently working with a small to mid-sized biopharmaceutical company focused on Oncology. My client has 6+ clinical trials, with 4 clinical trials being in Phase 2 or further. With multiple sites in the United States and they're looking to add headcount to their San Francisco location. We are looking for a QMS Specialist on a 6 month contract basis.
Responsibilities of the role:
Qualifications:
Best,
