QA Floor Ops Specialist II – On-the-Floor GMP Oversight

PCI Pharma Services; Bedford (NH); On-site; USD 80,000 - 100,000; Full time

Job summary

PCI Pharma Services is seeking a QA Operations Specialist II – Floor Support in Bedford, NH to provide on-the-floor QA oversight for manufacturing and visual inspection activities in a GMP facility. The role emphasizes real-time QA review of batch records, deviations, CAPA, and strict adherence to regulated standards.

The candidate will collaborate with Operations, QC, Facilities/Engineering, and Materials Management to resolve complex issues, perform audits, and ensure quality throughout the

Qualifications

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

Responsibilities

• Provide on-the-floor QA support for manufacturing and visual inspection activities.
• Observe formulation and aseptic processes; perform AQL visual inspections.
• Review GMP documentation and batch records; assist with deviations and CAPA.
• Cooperate with Operations, QC, Facilities/Engineering and Materials Management to resolve issues.
• Perform on-floor audits and room releases; ensure compliance with internal procedures.

Skills

RCA

Technical writing

Quality investigations

Lean operation

FDA regulations knowledge

ICH Q9 familiarity

Quality culture

Education

Bachelor's degree in a scientific field

Job description

PCI Pharma Services is seeking a QA Operations Specialist II – Floor Support in Bedford, NH to provide on-the-floor QA oversight for manufacturing and visual inspection activities in a GMP facility. The role emphasizes real-time QA review of batch records, deviations, CAPA, and strict adherence to regulated standards.

The candidate will collaborate with Operations, QC, Facilities/Engineering, and Materials Management to resolve complex issues, perform audits, and ensure quality throughout the