Gmp Quality Specialist Jobs in California

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

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