QA Operations Specialist II – Visual Inspection

PCI Pharma Services•Bedford, NH

1d•Onsite

About The Position

The QA Operations Specialist II – Visual Inspection supports visual inspection and final product sampling, packaging, storage, and shipment activities at PCI’s Bedford, New Hampshire site. The role primarily maintains timely product inspections, including Acceptable Quality Limits (AQL) and Bulk AQL, and supports the final product retain program and other visual inspection activities from a quality assurance and compliance perspective. The position works with QA Operations, Manufacturing, Visual Inspection, Materials Management, and Project Management.

Requirements

High school diploma.
Strong organizational skills and attention to detail.
Knowledge of FDA regulations, including 21 CFR Parts 210, 211, and 820, and some experience with international regulations such as ICH.
Ability to apply basic scientific principles to operational and routine quality tasks.
Scientific, technical, and mechanical subject matter comprehension and aptitude.
Ability to articulate scientific and technical subject matter.
Ability to maintain visual qualifications: 20/20 vision, corrected or uncorrected and checked annually; ability to see all colors and visually discern product specifications across multiple products.
Ability to work in a dynamic, fast-paced work environment.
Honesty, integrity, respect, and courtesy when working with colleagues.
Resilience through operational and organizational change.
Excellent interpersonal skills and ability to communicate orally and in writing.
Proficiency in MS Office, including Word and Excel.
Excellent verbal and written communication skills.

Nice To Haves

Bachelor’s degree in a relevant scientific field.
At least 3 years of experience in Visual Inspection, Quality Assurance, and/or Quality Control groups supporting pharmaceutical product manufacturing.

Responsibilities

Provide QA oversight and support for Visual Inspection activities.
Coordinate with cross-functional teams to improve procedures related to visual inspection, AQL, labeling, packaging, and final product release and shipments.
Monitor production and visual inspection schedules, support scheduling, and communicate factors that may affect planned activities.
Inspect final packaged lots and bulk packaging; support final product disposition, AQL inspections, sampling, and retains.
Create, review, and approve final product shipper and vial labels.
Conduct annual inspections of final product retains and support the final product retain program.
Ensure training and qualification status is current.
Review batch records and supporting GMP documentation.
Write and revise Standard Operating Procedures; maintain and evaluate processes and procedures and drive continuous improvement.
Conduct Media Fill inspections.
Support the final product reject inventory, defect library, and Visual Inspection Qualification kits.
Initiate and own Quality Systems activities such as Events, Deviations, and CAPAs.
Train and/or qualify new and less experienced staff members.
Work with cross-functional teams to schedule and prioritize activities appropriately.
Support site harmonization efforts related to Visual Inspection and QA Operations.
Represent QA-VI on internal project teams and collaborative activities, including scheduling, run-readiness, and batch-disposition meetings.
Assist QA-VI team members with scheduling and prioritizing daily activities.
Perform other duties as assigned.