QA On-the-Floor Specialist II – GMP Operations

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); Hybrid; USD 70,000 - 95,000; Full time

Job summary

PCI Pharma Services seeks a QA Operations Specialist II – Floor Support to provide on-the-floor QA oversight for manufacturing and visual inspection in a GMP facility. This role involves real-time review of batch records, deviations, and changeovers.

You will collaborate with Operations, QC, Facilities/Engineering, and Materials Management to resolve complex issues and support audits, ensuring regulatory compliance and product quality throughout clinically and commercially manufactured drug

Qualifications

• Bachelor’s degree in a relevant scientific field is required.
• Minimum 3 years’ experience in a GMP environment with quality exposure.
• ASQ certification is a plus.
• Experience with RCA, technical writing, and quality investigations.

Responsibilities

• On-the-floor QA oversight of manufacturing processes and visual inspection.
• Collaborate with Operations, QC, Facilities/Engineering, and Materials Management to resolve issues.
• Perform audits of manufacturing areas and ensure adherence to GMP procedures.
• Review batch records and approve deviations, CAPA, and changes as needed.
• Support internal, client, and regulatory audits and inspections.

Skills

GMP experience

Quality investigations

RCA

Technical writing

Education

Bachelor’s degree in a relevant scientific field

Job description

PCI Pharma Services seeks a QA Operations Specialist II – Floor Support to provide on-the-floor QA oversight for manufacturing and visual inspection in a GMP facility. This role involves real-time review of batch records, deviations, and changeovers.

You will collaborate with Operations, QC, Facilities/Engineering, and Materials Management to resolve complex issues and support audits, ensuring regulatory compliance and product quality throughout clinically and commercially manufactured drug