QA Compliance Specialist
SUMMARY / PURPOSE: Responsible for the review and release of drug substance from manufacturing activities and ensuring compliance with applicable GMP regulations. Assists in the development, implementation and maintenance of quality systems and other QA activities.
- Reviews batch records, deviations, investigations, documents, validation protocols, and reports for compliance to internal and GMP standards
- Write and revise Standard Operating Procedures as required
- Interacts with personnel from all departments to ensure GMP compliance
- Assists in the scheduling and maintenance of QA activities and systems
- Other general activities as assigned
EDUCATION REQUIRED (DEGREE / MAJOR / CERTIFICATIONS):
- Bachelors degree with 1-2 years experience working in a GMP environment.
- Experience with review and approval of GMP documentation including batch records and SOPS.