QA Visual Inspection Operations Specialist II

PCI Pharma Services; Bedford (NH); On-site; USD 65,000 - 90,000; Full time

Job summary

PCI Pharma Services in Bedford, NH is seeking a QA Operations Specialist II – Visual Inspection. This role supports Visual Inspection, final product sampling, labeling, and shipping from a QA perspective, ensuring AQL standards and retain programs are upheld.

You will collaborate with VI, Manufacturing, Materials Management and Project Management to maintain compliant processes, review batch records, and assist in training less experienced staff.

Qualifications

• High school diploma required.
• Strong organizational and attention to detail.
• Knowledge of FDA regulations (i.e., 21 CFR Part 210, 211 & 820) and some experience with international regulations such as ICH.
• Ability to read, interpret batch records and GMP documentation with accuracy.

Responsibilities

• Provide QA oversight and support of Visual Inspection activities.
• Coordinate with cross-functional teams to improve procedures related to visual inspection, AQL, labeling, packaging and final product release/shipments.
• Monitor production and visual inspection schedules and communicate factors impacting timing.
• Inspect final packaged lots, bulk packaging, final product disposition, AQL inspection, and sample retains.
• Create, review, and approve final product shipper and vial labels.
• Maintain final product retains program and conduct annual inspections.
• Ensure training and qualification status is in good standing.
• Review batch records and supporting GMP documentation.
• Write or revise Standard Operating Procedures as needed.
• Drive continuous improvement of processes and procedures.
• Support Visual Inspection qualification kits and related QA tasks.
• Initiate and own Quality Systems like Deviations, CAPAs, and Events.

Skills

Strong organizational skills

Attention to detail

Excellent communication (oral & writt)

MS Office (Word, Excel)

FDA regulations knowledge (21 CFR 210,

Education

High school diploma

Bachelor’s Degree in a relevant scientific field

Job description

PCI Pharma Services in Bedford, NH is seeking a QA Operations Specialist II – Visual Inspection. This role supports Visual Inspection, final product sampling, labeling, and shipping from a QA perspective, ensuring AQL standards and retain programs are upheld.

You will collaborate with VI, Manufacturing, Materials Management and Project Management to maintain compliant processes, review batch records, and assist in training less experienced staff.