Quality Assurance Specialist
Listed on 2026-10-20
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Quality Assurance - QA/QC
QA Specialist - Analyst/Manager, Regulatory Compliance Specialist, Production QC/QA, Quality Control - QC Analysts/Managers
The Quality Assurance Specialist is responsible to support day to day QA manufacturing activities such as but not limited to line clearance, real time batch record review, AQL sampling, and batch disposition. The QA Specialist ensures GMP compliance through real-time QA support to manufacturing. The role also owns the development, implementation, and continuous improvement of quality procedures that govern operational activities.
This includes writing, revising, and deploying SOPs and work instructions to support sterile manufacturing, qualification activities, and operational readiness. The role reports to the Site Quality Head and will support site inspection readiness and quality culture initiatives
Key Responsibilities
- Provide daily quality oversight during manufacturing, warehousing, and qualification activities, including but not limited to line clearance and AQL sampling.
- Ensure adherence to cGMP, SOPs, and regulatory standards.
- Lead and execute QA review of batch records, logbooks, and related GMP documentation to support timely and accurate product disposition.
- Develop, implement, and maintain site-specific quality procedures (SOPs, work instructions, forms) governing QA support responsibilities
- Ensure proper execution of Good Documentation Practices (GDP) and data integrity in all manufacturing executed records.
- Take active role in preparing the site for regulatory inspection,
- Act as a QA representative during regulatory inspections, internal audits, and customer audits.
Contribute to the inspection readiness of the site, including periodic walkthroughs and risk-based quality improvements.
Qualifications / Experience
- Bachelor’s degree in a scientific or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering)
- 5+ years of experience in pharmaceutical manufacturing, or QA.
- Familiarity with aseptic manufacturing, sterile injectable processes, and cleanroom environments
- Knowledge of FDA cGMPs, ICH Q8-Q10 guidelines, EU Annex 1, and risk-based qualification approaches
- Experience supporting regulatory inspections and validation documentation reviews
- Strong knowledge of 21 CFR part 10, and 211,
- Strong knowledge of aseptic GMP manufacturing and QA shopfloor support.
- Excellent organizational and communication skills with high attention to detail
- Ability to work collaboratively with operations, and engineering
- Commitment to data integrity, continuous improvement, and patient safety
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