QA Reviewer

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