QA Specialist I: GxP, CAPA & Batch Release Expert

PCI Pharma Services; Tennessee; On-site; USD 60,000 - 78,000; Full time

Job summary

PCI Pharma Services seeks a QA Specialist I to ensure quality of products and compliance with internal procedures and external standards. You will review batch records, disposition lots, and oversee CAPAs and investigations to maintain GxP compliance for clinical and commercial products.

The role requires performing risk-based decisions, collaborating with cross-functional teams, and contributing to continuous quality improvements in a fast-paced environment.

Qualifications

• Experience performing RCA, technical writing, and working with quality related investigations.
• Knowledge of laboratory and production equipment and IQ/OQ/PQ.
• Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience with ICH.
• Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9.
• Bachelor’s Degree in a relevant scientific discipline with 5-7 years in pharma/biotech and 3+ years QA Operations.

Responsibilities

• Review batch documentation for release in compliance with cGMPs and site SOPs.
• Review and approve master batch records for timely initiation of manufacturing activities.
• Oversee deviation/investigation and CAPA programs and monitor quality system events.
• Review and approve investigations in support of batch release and GMP compliance.
• Lead complex investigations and CAPAs and ensure timely status updates.

Skills

RCA investigations

Technical writing

Investigations support

Education

Bachelor's degree in science

Tools

IQ/OQ/PQ

Job description

PCI Pharma Services seeks a QA Specialist I to ensure quality of products and compliance with internal procedures and external standards. You will review batch records, disposition lots, and oversee CAPAs and investigations to maintain GxP compliance for clinical and commercial products.

The role requires performing risk-based decisions, collaborating with cross-functional teams, and contributing to continuous quality improvements in a fast-paced environment.