Job Description
Job Description
Location: Fully On-Site
Duration: 6+ Months
Position Summary
We are seeking an experienced QA Reviewer to support quality oversight and documentation review activities within a regulated biopharmaceutical manufacturing environment. This role is responsible for ensuring that all documentation meets cGMP standards, internal procedures, and regulatory expectations.
Key Responsibilities
- Review and approve characterization and packaging validation protocols and reports
- Perform QA review of C&Q (Commissioning & Qualification) documentation (IQ/OQ/PQ)
- Review and approve Change Control records, ensuring proper impact and risk assessments
- Review Deviations, ensuring accurate root cause analysis and appropriate CAPAs
- Review technical assessments and validation documentation for compliance and completeness
- Ensure adherence to cGMP, GDP, and ALCOA+ data integrity principles
- Support audit readiness and inspection activities
- Collaborate with Engineering, Validation, Manufacturing, and Quality teams to resolve documentation gaps
- Ensure documentation is complete, accurate, and audit-ready
Qualifications
- Bachelor’s degree in Science, Engineering, or related field (preferred)
- 5+ years of experience in QA or Validation within a pharmaceutical/biotech environment
- Strong experience reviewing validation documentation (C&Q, Characterization, Packaging Validation)
- Experience with Deviations, Change Control, and CAPA systems
- Knowledge of cGMP, FDA regulations, and data integrity principles (ALCOA+)
- Strong attention to detail and ability to work in a fast-paced environment
Additional Information
- Fully on-site role
- Immediate availability preferred
- Experience in large-scale biologics or sterile manufacturing environments is a plus