QA On-the-Floor Specialist II (GMP)

PCI Pharma Services; Bedford (NH); On-site; USD 70,000 - 95,000; Full time

Job summary

PCI Pharma Services in Bedford, NH is seeking a QA Operations Specialist II to provide on-the-floor QA support for manufacturing and visual inspection of clinical and commercial drug product in a GMP facility.

You will perform real-time QMS activities, review batch records, and coordinate with Operations, QC, Facilities, and Project Management to resolve issues. The role emphasizes cGMP compliance, deviations, CAPA, and continuous quality improvement.

Qualifications

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

Responsibilities

• Perform QA on-the-floor activities supporting client projects, including room release and auditing critical processes.
• Review GMP documentation in real time and resolve issues that occur during manufacturing.
• Consult with Operations, QC, Facilities/Engineering, Project Management to resolve complex situations.
• Batch record review for adherence to internal procedures and Good Documentation Practices.
• Support the evaluation and disposition of intermediates, finish product, and raw materials.
• QA review and approval of new and revised GMP documents such as SOPs and material specs.
• Initiate deviations, CAPA, and nonconformances; participate in internal audits.

Skills

GMP experience

Quality assurance

Auditing

Technical writing

Problem solving

Education

Bachelor's degree in a relevant scientific field

Job description

PCI Pharma Services in Bedford, NH is seeking a QA Operations Specialist II to provide on-the-floor QA support for manufacturing and visual inspection of clinical and commercial drug product in a GMP facility.

You will perform real-time QMS activities, review batch records, and coordinate with Operations, QC, Facilities, and Project Management to resolve issues. The role emphasizes cGMP compliance, deviations, CAPA, and continuous quality improvement.