QA Floor Operations Specialist II – GMP Manufacturing

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); On-site; USD 70,000 - 90,000; Full time

Job summary

PCI Pharma Services in Bedford, NH seeks a QA Specialist II – Ops/Floor Support to provide QA oversight for manufacturing and visual inspection of clinical and commercial drug products in a GMP facility. The role involves real-time review of batch records, training, and rapid issue resolution to ensure compliance.

You will collaborate with Operations, QC, Facilities, and Project Management, performing audits, deviations, and CAPA initiation, while supporting site quality initiatives and client

Qualifications

• Minimum 3 years in GMP, with at least 1 year in Quality.
• Experience with RCA, nonconformances, deviations, and CAPA.
• Familiarity with FDA regulations (21 CFR) and ICH guidelines.

Responsibilities

• Provide on-the-floor QA support for manufacturing and visual inspection activities.
• Review and approve GMP documentation and batch records in real time.
• Investigate quality events and initiate appropriate corrective actions.
• Perform room releases, audits, and equipment/utility monitoring data review.
• Co-own nonconforming material investigations and QA approvals of documents.

Skills

GMP experience on-the-floor

QA investigations

Root cause analysis

Technical writing

On-the-floor quality oversight

Education

Bachelor’s degree in a relevant scientific field

ASQ certification (plus)

Job description

PCI Pharma Services in Bedford, NH seeks a QA Specialist II – Ops/Floor Support to provide QA oversight for manufacturing and visual inspection of clinical and commercial drug products in a GMP facility. The role involves real-time review of batch records, training, and rapid issue resolution to ensure compliance.

You will collaborate with Operations, QC, Facilities, and Project Management, performing audits, deviations, and CAPA initiation, while supporting site quality initiatives and client