GMP QA Floor Operations Specialist I

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

Job summary

PCI Pharma Services in Bedford, NH seeks an QA Operations Specialist I - Floor Support to provide on-the-floor QA oversight of manufacturing and visual inspection activities for clinical and commercial products in a GMP facility. Responsibilities include real-time documentation review, room release, and support for processing deviations and CAPA initiatives.

The role requires a Bachelor’s in a scientific field, 2+ years in GMP, and strong QA process knowledge.

Qualifications

• Bachelor's Degree in a relevant scientific field.
• Minimum 2 years' experience in a GMP environment preferred.
• Experience with RCA, technical writing, and investigations helpful.

Responsibilities

• Perform on-the-floor QA activities supporting client projects, including room release and real-time GMP documentation review.
• Conduct periodic walkthroughs of manufacturing and support areas to ensure policy adherence.
• Review and disposition of batch records and incoming materials per SOPs and quality standards.
• Assist in nonconforming material investigations and in CAPA/Deviations workflows.

Skills

QA on-the-floor

GMP documentation

Regulatory knowledge

Education

Bachelor's Degree in a relevant scientific field

Tools

MS Office

Job description

PCI Pharma Services in Bedford, NH seeks an QA Operations Specialist I - Floor Support to provide on-the-floor QA oversight of manufacturing and visual inspection activities for clinical and commercial products in a GMP facility. Responsibilities include real-time documentation review, room release, and support for processing deviations and CAPA initiatives.

The role requires a Bachelor’s in a scientific field, 2+ years in GMP, and strong QA process knowledge.