QA Specialist I: GMP & CAPA for Life-Saving Therapies

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); On-site; USD 65,000 - 85,000; Full time

Job summary

PCI Pharma Services in Bedford, New Hampshire, seeks a QA Specialist I to ensure product quality and regulatory compliance. Responsibilities include batch record review, deviation investigations, CAPAs, and change control oversight in a fast-paced GxP environment.

The role requires 3+ years in QA operations within pharmaceutical/biotech; a BA/BS in a relevant science is preferred, along with familiarity with FDA regulations and ICH guidelines.

Qualifications

• Bachelor’s degree in a relevant scientific discipline with 5–7 years of pharma/biotech experience and 3+ years in QA operations.
• Experience performing RCA and quality investigations.
• Knowledge of FDA regulations (21 CFR Parts 210, 211, 820) and ICH guidelines.
• Ability to work in a fast-paced environment and communicate effectively.

Responsibilities

• Review batch documentation for release under cGMP and regulatory requirements.
• Prioritize batch record review to support business needs and communicate release status.
• Review and approve master batch records for timely initiation of manufacturing.
• Oversee deviation investigations, CAPAs, and related quality system activities.
• Coordinate change controls and ensure timely closure with documentation.

Skills

RCA experience

Quality investigations

FDA regulations knowledge

IQ/OQ/PQ knowledge

Risk management tools

MS Office proficiency

Strong communication

Detail-oriented

Education

Bachelor’s degree in a relevant scientific discipline

ASQ certification (preferred)

Tools

MS Office

Job description

PCI Pharma Services in Bedford, New Hampshire, seeks a QA Specialist I to ensure product quality and regulatory compliance. Responsibilities include batch record review, deviation investigations, CAPAs, and change control oversight in a fast-paced GxP environment.

The role requires 3+ years in QA operations within pharmaceutical/biotech; a BA/BS in a relevant science is preferred, along with familiarity with FDA regulations and ICH guidelines.