- Responsible for batch record review and disposition of API and Drug Product lots with reference to approved specifications.
- Review, revise and maintain standard operational procedures (SOP) and specifications.
- Review for administration of deviations, out of specification (OOS), and out of trend (OOT) events and participate in preparation of reports.
- Create and administer change control records and follows up on completion of changes.
- Participate in risk assessment and gap assessment as it relates to maintaining compliance with safety, quality and regulatory standards.
- Facilitate employee training on current SOPs according to GxP requirements and archives training records.
- Experienced in MasterControl Quality Management System, especially as a system administrator.
- Experienced in making independent decisions related to controlled document management.
- Responsible for GxP controlled document management and archiving.
- Responsible for attaining and archiving of relevant records from CMOs and Contract labs.
- Perform activities to maintain and improve quality systems.
- Other responsibilities include supporting manufacturing, clinical operations, and supply chain departments as necessary.
- Knowledge of GMP rules and regulations and ICH guidelines
- Bachelor's or Master's degree in chemistry or one of the life science disciplines
- Minimum 5 years' experience Quality Assurance of Pharmaceutical/ biotech industries
- Knowledge and experience with MasterControl as a system administrator with special focus on quality systems, document management, and training modules
- Proficient in Word, Excel, and PowerPoint
- Strong verbal and written communications skills
- A team player
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Quality Assurance Specialist
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Quality Assurance Specialist
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PSG Global Solutions San Francisco, United StatesWe're looking for a · Quality Assurance Specialist , working in · Pharmaceuticals · and · Medical Products · industry in · 121 Oyster Point Boulevard, South San Francisco, California, 94080, United States . · Job description: · Reviews computer system validation documenta ...
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WestEd San Francisco, United States Part timeAbout WestEd · As a community of over1,300researchers, practitioners, consultants, and administrative professionals from all backgrounds and life experiences, we are committed to making a qualitative difference in the lives of youth, children, and adults. We conduct and apply re ...
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Bausch Health San Francisco, United StatesBausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry. We are delivering on ...
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PSG Global Solutions Careers South San Francisco, United StatesApply now and our proprietary system will quickly have you in front of a live recruiter. · The Opportunity · Description · We're looking for a Quality Assurance Specialist, working in Pharmaceuticals and Medical Products industry in 121 Oyster Point Boulevard, South San Franci ...
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Quality Assurance Specialist
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PSG Global Solutions Careers South San Francisco, United StatesApply now and our proprietary system will quickly have you in front of a live recruiter. The Opportunity Description We're looking for a Quality Assurance Specialist, working in Pharmaceuticals and Medical Products industry in 121 Oyster Point Boulevard, South San Francisco, Cali ...
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Abbott Laboratories company Alameda, United StatesSpecialist Quality Assurance page is loaded · Specialist Quality Assurance · Apply · locations · United States - California - Alameda · time type · Full time · posted on · Posted 2 Days Ago · job requisition id · Abbott is a global healthcare leader that helps people li ...
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Specialist Quality Assurance
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Abbott Laboratories company Alameda, United StatesSpecialist Quality Assurance page is loaded · Specialist Quality Assurance · Apply · locations · United States - California - Alameda · time type · Full time · posted on · Posted 2 Days Ago · job requisition id · Abbott is a global healthcare leader that helps people li ...
Senior Quality Assurance Specialist - San Francisco, United States - Jaguar Health
Description
REQUIREMENTS