QA On-Floor Specialist II — GMP Operations

PCI Pharma Services; Bedford (NH); On-site; USD 75,000 - 110,000; Full time

Job summary

PCI Pharma Services in Bedford, NH, is seeking a QA Specialist II - Ops/Floor Support to provide on-the-floor QA oversight for manufacturing and visual inspection in a GMP facility. The role includes real-time review of GMP docs, batch records, and line changeovers, with cross-functional interaction across Operations, QC, Facilities, and Materials Management.

The ideal candidate holds a relevant science degree with 3+ years in GMP, plus familiarity with RCA and quality investigations.

Qualifications

• Bachelor's degree in a scientific field is required.
• Minimum 3 years' experience in a GMP environment, with at least 1 year in Quality.
• ASQ certification is a plus.
• Exposure to RCA, technical writing, and quality investigations.

Responsibilities

• On-the-floor QA support for manufacturing and visual inspection activities.
• Review GMP documentation and batch records in real time; support deviations and CAPA as needed.
• Collaborate with Operations, QC, Facilities/Engineering, and Materials Management to resolve issues.
• Perform on-floor room release, audits of critical processes, and interdepartmental interactions.

Education

Bachelor's degree in a relevant scientific field

Tools

Job description

PCI Pharma Services in Bedford, NH, is seeking a QA Specialist II - Ops/Floor Support to provide on-the-floor QA oversight for manufacturing and visual inspection in a GMP facility. The role includes real-time review of GMP docs, batch records, and line changeovers, with cross-functional interaction across Operations, QC, Facilities, and Materials Management.

The ideal candidate holds a relevant science degree with 3+ years in GMP, plus familiarity with RCA and quality investigations.