Senior QA Visual Inspection Lead — Global Impact

PCI Pharma Services; Bedford (NH); On-site; USD 85,000 - 110,000; Full time

Job summary

PCI Pharma Services in Bedford, NH is seeking a Sr. QA Operations Specialist focused on Visual Inspection. You will support QA oversight of VI activities, manage AQL processes, labeling, and final product release, and collaborate with Manufacturing, Materials Management, and Project Management.

You will maintain training, review batch records, and own SOP updates while contributing to process improvements in a fast-paced pharmaceutical environment.

Qualifications

• High school diploma required.
• Strong organizational skills and attention to detail.
• Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience with international regulations such as ICH.
• Ability to apply basic scientific principles to solve operational, as well as routine quality tasks.
• Scientific, technical, and mechanical subject matter comprehension and aptitude.
• Excellent verbal and written communication skills; proficient in MS Office.

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 final product sampling and retains.
• Create, review, and approve final product shipper and vial labels.
• Maintain training and qualification status in good standing.
• Review batch records and GMP documentation; own SOPs writing or revisions.
• Drive continuous improvement of processes and procedures; participate in quality events.

Skills

Organization

Attention to detail

Regulatory knowledge

Scientific principles

Communication skills

MS Office proficiency

Education

Bachelor's degree in a scientific field

Tools

MS Word

MS Excel

Job description

PCI Pharma Services in Bedford, NH is seeking a Sr. QA Operations Specialist focused on Visual Inspection. You will support QA oversight of VI activities, manage AQL processes, labeling, and final product release, and collaborate with Manufacturing, Materials Management, and Project Management.

You will maintain training, review batch records, and own SOP updates while contributing to process improvements in a fast-paced pharmaceutical environment.