Title: QA Auditor - Pharmaceutical
Location: Tewksbury, MA
Type: Full time, permanent
Salary: Commensurate with experience
- Audits, across multiple sites, raw material manufacture, suppliers of API, excipients, packaging components, and firms providing GMP services such as laboratories and others as required.
- Independently conducts internal and external audits
- Independently performs evaluations of quality systems and practices to identify potential problems such as Non-Conformance to applicable SOPs and Quality Standards
- Tracks audit responses and CAPA until completion and closeout.
- Performs evaluations of quality systems and practices to identify potential problems such as Non-Conformance to applicable SOPs and quality standards (GMP, ICH, ISO, IPEC, etc.), coordinates resolutions, and provides guidance on quality/compliance risk levels.
- Minimum of a BS degree in Science or Pharmaceutical studies with a minimum of 5 years' experience in a pharmaceutical manufacturing or Quality Assurance environment.
- Knowledge of FDA regulations, GMP/GLP/GCP, ISO 9001, and other quality management systems
- Demonstrates the ability to review investigations, change control, analytical data, test reports, batch records and certificates of analysis and other technical documents.
- Demonstrates the ability to conduct GMP audits & investigations