QA Operations Lead, Visual Inspection — Global Impact

PCI Pharma Services; Bedford (NH); On-site; USD 90,000 - 110,000; Full time

Job summary

PCI Pharma Services in Bedford, NH seeks a Sr. QA Operations Specialist – Visual Inspection to support final product sampling, labeling, and shipping while maintaining AQL programs and QA oversight.

You will collaborate with VI, Manufacturing and PM teams to schedule activities, review batch records, update SOPs, and train staff in QA procedures at a fast-paced pharmaceutical site. This role requires meticulous attention to detail and strong regulatory knowledge.

Qualifications

• High school diploma required.
• Strong organizational skills and attention to detail.
• Knowledge of FDA regulations (e.g., 21 CFR Parts 210, 211 & 820) and ICH familiarity preferred.
• Ability to apply basic scientific principles to solve operational quality tasks.
• Proficiency in MS Office including Word and Excel.
• Excellent written and verbal communication skills.

Responsibilities

• Provide QA oversight and support of Visual Inspection related activities.
• Coordinate with cross-functional teams to improve procedures for visual inspection, AQL, labeling, packaging and final product release/shipments.
• Support scheduling by monitoring production and visual inspection schedules and communicating potential delays.
• Inspect final packaged lots, bulk packaging, final product disposition, AQL inspection, and retains.
• Create, review, and approve final product shipper and vial labels.
• Review batch records and GMP documentation; maintain training status and SOPs.
• Drive continuous improvement and participate in QA project teams.

Skills

Attention to detail

Organization

MS Office

Communication skills

Education

High school diploma

Bachelor’s Degree in a relevant field

Tools

MS Office (Word/Excel)

Job description

PCI Pharma Services in Bedford, NH seeks a Sr. QA Operations Specialist – Visual Inspection to support final product sampling, labeling, and shipping while maintaining AQL programs and QA oversight.

You will collaborate with VI, Manufacturing and PM teams to schedule activities, review batch records, update SOPs, and train staff in QA procedures at a fast-paced pharmaceutical site. This role requires meticulous attention to detail and strong regulatory knowledge.