Overview
Quality Assurance (QA) Reviewer – GMP Compliance Jobs in Fairfield, NJ at Stira Pharmaceuticals
Title: Quality Assurance (QA) Reviewer – GMP Compliance
Company: Stira Pharmaceuticals
Location: Fairfield, NJ
Job Title: Quality Assurance (QA) Reviewer – GMP Compliance
Job Summary:
The QA Reviewer is responsible for ensuring that all analytical, laboratory, and manufacturing documentation complies with current Good Manufacturing Practices (cGMP) and internal quality standards. This role plays a critical part in batch release, document control, and maintaining inspection readiness by conducting thorough reviews and supporting cross-functional compliance activities.
Key Responsibilities:
- Review analytical raw data to ensure accuracy of data, calculations, and adherence to proper documentation practices
- Support batch release activities by verifying that all required documentation is complete, accurate, and approved
- Review validation reports, study reports, laboratory records, and GMP documents for completeness and regulatory compliance
- Ensure compliance with cGMP, GDP (Good Documentation Practices), SOPs, and data integrity requirements
- Review and assess deviations, Change Controls, Out-of-Specification (OOS) results, laboratory investigations, and CAPA for adequacy, accuracy, and timely closure
- Identify documentation errors, discrepancies, or missing information and coordinate necessary corrections with relevant teams
- Maintain proper documentation to ensure continuous audit and inspection readiness
- Collaborate with Production, Quality Control (QC), and other departments to ensure timely reviews and compliance with quality standards
- Manage document control activities including issuance, revision, distribution, archival, and retrieval in accordance with GMP requirements and internal procedures
Qualifications:
- Bachelor’s degree in Chemistry, Pharmacy, Microbiology, or a related scientific field
- 2–3 years of experience in Quality Assurance within a GMP-regulated environment (pharmaceutical, biotech, or related industry)
- Strong knowledge of cGMP, GDP, data integrity principles, and regulatory expectations
- Experience with batch record review and document control systems
- Team collaboration and cross-functional coordination
Application:
Email your resume/cover letter directly to [email protected].
