Senior QA Specialist: GxP, CAPA & Batch Release

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); Hybrid; USD 65,000 - 90,000; Full time

Job summary

PCI Pharma Services, located in Bedford, New Hampshire, seeks a QA Specialist I to ensure product quality and regulatory compliance. The role emphasizes batch record review, lot disposition, deviations, CAPAs and change controls.

The position offers collaboration with cross-functional teams to support both clinical and commercial product manufacturing. The candidate will oversee QA documentation, participate in internal audits, and contribute to regulatory inspection readiness, driving

Qualifications

• Bachelors in a scientific field; 5–7 years pharma/biotech QA exp preferred.
• Experience with RCA, deviations, CAPA processes and change controls.
• Familiarity with FDA regulations (21 CFR 210/211/820) and ICH guidance.
• Proficient in technical writing and documentation
• Strong organizational and communication skills.

Responsibilities

• Review batch records for release and compliance with cGMPs and SOPs.
• Oversee deviation/investigation and CAPA programs; provide QA approvals.
• Review/approve manufacturing, QC investigations and change controls.
• Lead quality system events, risk assessments, and regulatory inspections readiness.
• Interface with clients and cross-functional teams to address documentation concerns.

Skills

RCA

Tech writing

GxP knowledge

QA investigations

Communication

Education

Bachelor's Degree (scientific)

Tools

MS Office

Word

Excel

Access

Visio

Job description

PCI Pharma Services, located in Bedford, New Hampshire, seeks a QA Specialist I to ensure product quality and regulatory compliance. The role emphasizes batch record review, lot disposition, deviations, CAPAs and change controls.

The position offers collaboration with cross-functional teams to support both clinical and commercial product manufacturing. The candidate will oversee QA documentation, participate in internal audits, and contribute to regulatory inspection readiness, driving