Senior QA Specialist: GMP Compliance & CAPA Leader

PCI Pharma Services; Bedford (AL); On-site; USD 70,000 - 90,000; Full time

Job summary

PCI Pharma Services’ Bedford, NH site is seeking a QA Specialist I to ensure product quality and regulatory compliance across clinical and commercial production. You will perform batch record review, CAPA management, deviation investigations, and contribute to GxP program improvements.

The role requires strong knowledge of cGMPs, regulatory requirements and QA systems, with 5–7 years in pharma/biotech QA. Collaboration with cross-functional teams and preparation for inspections are key aspects

Qualifications

• Experience performing RCA, technical writing, and quality investigations.
• Knowledge of laboratory and production equipment and IQ/OQ/PQ.
• FDA regulations (21 CFR Part 210, 211 & 820) and familiarity 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 pharma/biotech experience and 3+ years QA Operations.
• ASQ certification preferred
• Excellent organizational skills and attention to detail.

Responsibilities

• Review batch documentation for release per cGMPs and regulatory requirements.
• Approve master batch records for initiation of GxP manufacturing activities.
• Oversee deviation/investigation and CAPA programs.
• Review investigations across Manufacturing, Quality Control and others for batch release and GMP compliance.
• Provide direction for complex investigations and CAPAs.
• Track change controls and provide status reports; participate in management review.
• Collaborate with internal/external customers on quality and compliance matters.
• Lead quality system improvement projects and communicate status.
• Ensure site readiness for regulatory inspections.
• Provide training on department procedures and systems.

Skills

RCA experiences

Technical writing

Quality investigations

Education

Bachelor’s Degree in a relevant science

Tools

MS Office (Word, Excel, Access, Visio)

IQ/OQ/PQ

Job description

PCI Pharma Services’ Bedford, NH site is seeking a QA Specialist I to ensure product quality and regulatory compliance across clinical and commercial production. You will perform batch record review, CAPA management, deviation investigations, and contribute to GxP program improvements.

The role requires strong knowledge of cGMPs, regulatory requirements and QA systems, with 5–7 years in pharma/biotech QA. Collaboration with cross-functional teams and preparation for inspections are key aspects