QA Specialist I — GxP Quality, CAPA & Batch Release

PCI Pharma Services; Bedford (AL); On-site; USD 65,000 - 90,000; Full time

Job summary

PCI Pharma Services is seeking a QA Specialist I in Bedford, NH to ensure product quality and regulatory compliance across clinical and commercial productions. You will perform batch record reviews, approve master batch records, and oversee deviation investigations and CAPAs in a fast-paced, cGMP environment.

The role requires a scientific degree, 5–7 years in pharma/biotech QA operations, and strong communication skills to collaborate with cross-functional teams and support regulatory readiness.

Qualifications

• Strong knowledge of cGMPs and FDA regulations.
• Experience with deviation investigations and CAPAs.
• Bachelor's degree in a science field.
• 5–7 years in pharma/biotech with QA operations 3+ years.
• Excellent written and verbal communication.

Responsibilities

• Review batch documentation for release under cGMPs and SOPs.
• Review and approve master batch records for manufacturing.
• Oversee deviation investigations and CAPAs.
• Manage change controls and document approvals.
• Provide QA guidance to technical transfer and process validation.
• Prepare status reports and quality metrics.

Skills

RCA

Technical writing

Quality investigations

Regulatory knowledge

MS Office

Communication skills

Education

Bachelor’s Degree in scientific discipline

ASQ certification

Tools

IQ/OQ/PQ

GxP systems

Job description

PCI Pharma Services is seeking a QA Specialist I in Bedford, NH to ensure product quality and regulatory compliance across clinical and commercial productions. You will perform batch record reviews, approve master batch records, and oversee deviation investigations and CAPAs in a fast-paced, cGMP environment.

The role requires a scientific degree, 5–7 years in pharma/biotech QA operations, and strong communication skills to collaborate with cross-functional teams and support regulatory readiness.