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Quality Assurance Gmp Trainer Jobs in California

Quality Assurance Specialist - Gmp
By Revvity At , San Diego
Preferred Qualifications – Education and Experience
Investigate product quality issues and ensure resolution in accordance with company guidelines and regulatory requirements
Participate in and support the facility in internal, customer, and third-party audits per ISO 13485 requirements
Create and modify SOPs with support from supervisor/manager
Other projects or responsibilities as may be required.
Knowledge of concepts, methods, terminologies, and tools of quality assurance
Assoc Gmp Quality Assurance Director - Clinical
By Exelixis, Inc. At , Alameda, 94502 $146,000 - $207,500 a year
Equivalent combination of education and experience.
Manages QA review of manufacturing records, clinical trial documentation and documents submitted to regulatory agencies.
Oversees and manages the GMP auditing process, and all other relevant QA inspectional activities.
BS/BA degree in related discipline and a minimum of 11 years of related QA experience; or,
MS/MA degree in related discipline and a minimum of 9 years of related QA experience; or,
PhD in related discipline and a minimum of 5 years of related QA experience; or
Associate Director, Gmp Quality Assurance
By BioSpace At South San Francisco, CA, United States
Knowledge of Quality Management Systems; experience in implementing and managing quality systems (paper based and Veeva EDMS) in the pharmaceutical industry.
Support the implementation of GMP and GLP activities as required by internal procedures and application of regulatory requirements.
Minimum 10 years of GMP Quality Assurance experience with GLP experience a plus.
Strong understanding of small molecule manufacturing with direct experience in solid oral dosage forms.
Knowledge in clinical development to commercial is desired.
Hands-on experience in manufacturing and/or analytical testing and development.
Quality Assurance Associate Ii, Gmp Systems Compliance And Data Integrity
By Catalent At , San Diego, 92121, Ca $75,000 - $85,000 a year
Review and approval of equipment related documentation: Equipment onboarding, Calibration certificates/reports, Validation/qualification reports.
Assisting with plans, procedures, and requirements to address data integrity gaps for GMP systems.
Candidate must have 2+ years of work experience, preferable in a GMP manufacturing environment or similar.
Experience with equipment verification/calibration and supporting documentation highly desired.
Experience with Blue Mountain, TrackWise, and Microsoft Office preferred.
Medical, dental and vision benefits effective day one of employment
Quality Assurance Associate - Gmp Biomanufacturing Center
By CEDARS-SINAI At , Los Angeles, Ca $24.82 - $37.23 an hour
Assists with document control and records management.
No experience is required. Three (3) years of experience in Quality or Regulatory compliance is preferred.
Assist in the first-level enforcement of quality processes in compliance with quality procedures.
Assists review of manufacturing processes and cGMP documents following procedures and policies.
Assists in performing root cause analysis and establishing corrective and preventative actions.
Initiates corrective action in accordance with procedures.
Quality Assurance Specialist - Gmp
By Integrated Resources, Inc ( IRI ) At San Diego, CA, United States
Strong interpersonal skills, time management, and organizational skills
Strong Document Control skills and knowledge
May include other duties as defined by the Document Control department management.
Bachelors degree, equivalent college courses or equivalent experience
Years (3+) of related work experience preferred
Experience using Oracle Agile PLM software preferred