QA Floor Lead – GMP Manufacturing & Compliance

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); On-site; USD 75,000 - 105,000; Full time

Job summary

PCI Pharma Services is seeking a QA Specialist II – Ops/Floor Support in Bedford, NH. You will provide on-the-floor QA oversight of manufacturing and visual inspection, perform real-time GMP documentation review, and support continuous quality improvements in a GMP facility.

The role emphasizes collaboration with Operations, QC, Facilities, and Project Management to resolve complex quality issues and ensure regulatory compliance.

Qualifications

• Bachelor’s degree in a relevant scientific field.
• Minimum 3 years’ experience in relevant GMP industry, with minimum 1 year experience in Quality, or Equivalent combination of education and experience.
• ASQ certification is a plus.
• Exposure to lean operation excellence highly desirable.
• Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
• Knowledge and ability to apply basic scientific principles to solve operational, as well as routine quality tasks
• Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9 #LI-RS1

Responsibilities

• Provide on-the-floor QA for client projects, including room release.
• Audit manufacturing areas and review GMP documentation in real time.
• Consult with Operations, QC, Facilities/Engineering, Project Management, and Materials Management to resolve issues.
• Lead QA investigations and CAPA initiation as needed.
• Review batch records for compliance with procedures and Good Documentation Practices.
• Support disposition of materials and products and review incoming materials.
• Participate in client audits and regulatory inspections.
• Train and coach staff on QA processes and quality systems.

Skills

QA on-the-floor

GMP Compliance

Auditing

Cross-functional Communication

Regulatory Knowledge

Education

Bachelor’s degree in sciences

Job description

PCI Pharma Services is seeking a QA Specialist II – Ops/Floor Support in Bedford, NH. You will provide on-the-floor QA oversight of manufacturing and visual inspection, perform real-time GMP documentation review, and support continuous quality improvements in a GMP facility.

The role emphasizes collaboration with Operations, QC, Facilities, and Project Management to resolve complex quality issues and ensure regulatory compliance.