QA Floor Support Specialist I – GMP & Compliance

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

Job summary

PCI Pharma Services in Bedford, New Hampshire is seeking a QA Operations Specialist I - Floor Support to provide on-the-floor QA oversight of manufacturing and visual inspection for clinical and commercial drug products in a GMP facility.

The role includes batch record review, disposition of materials, SOP review, CAPA initiation, and real-time monitoring to ensure regulatory compliance and product quality, requiring strong collaboration with manufacturing teams.

Qualifications

• Bachelor's degree in a relevant scientific field required.
• Minimum 2 years in GMP industry preferred.
• Familiar with FDA 21 CFR Part 210, 211 & 820 and ICH.
• Experience with RCA and quality investigations.

Responsibilities

• Perform on-the-floor QA during client projects, including room release and GMP document review.
• Conduct walkthroughs of manufacturing areas for policy adherence.
• Review batch records for GMP compliance and proper documentation.
• Assist in disposition of materials and review of incoming items.
• Support quality investigations and CAPA initiation as needed.

Skills

On-the-floor QA

GMP documentation

Root cause analysis

Quality systems

Communication

Education

Bachelor's Degree in a relevant scientific field

Tools

MS Office

Excel

Job description

PCI Pharma Services in Bedford, New Hampshire is seeking a QA Operations Specialist I - Floor Support to provide on-the-floor QA oversight of manufacturing and visual inspection for clinical and commercial drug products in a GMP facility.

The role includes batch record review, disposition of materials, SOP review, CAPA initiation, and real-time monitoring to ensure regulatory compliance and product quality, requiring strong collaboration with manufacturing teams.