QA Specialist II

Responsibilities

• Perform review of batch documentation for release of clinical and commercial products to ensure compliance with cGMPs and regulatory requirements
• Provide quality oversight and administration for deviation, investigation, and CAPA programs
• Review and approve master batch records, manufacturing investigations, and change control documentation
• Lead complex investigations and provide direction for corrective and preventive actions (CAPAs)
• Monitor and propose quality process and system improvements to enhance GxP programs
• Serve as the QA representative for cross-functional project teams, including tech transfer and process validation
• Perform risk assessments to comply with internal procedures and external guidelines
• Ensure site readiness for regulatory inspections and interface with clients regarding compliance concerns

Requirements

• Bachelor’s Degree in a relevant scientific discipline
• 5-7 years of pharmaceutical or biotech industry experience
• 3+ years of QA Operations experience supporting late-stage clinical or commercial production
• Proven experience performing Root Cause Analysis (RCA) and technical writing
• Strong knowledge of FDA regulations, specifically 21CFR Part 210, 211, and 820
• Experience using Risk Management Tools such as FMEA, HACCP, or PHA
• Familiarity with ICH Q9 guidelines

Preferred Qualifications

• ASQ certification
• Knowledge of laboratory and production equipment and IQ/OQ/PQ processes
• Proficiency in MS Office (Word, Excel, Access, and Visio)
• Ability to make risk-based decisions with minimal guidance in a fast-paced environment

About the Company

PCI Pharma Services is a global provider of pharmaceutical services, dedicated to building the bridge between life-changing therapies and the patients who need them. We invest in people who drive progress and create a better tomorrow through operational excellence and a culture of purposeful work.