Sr. QA Operations Specialist – Visual Inspection

PCI Pharma Services•Bedford, NH

1d•Onsite

About The Position

The Sr. QA Operations Specialist – Visual Inspection supports visual inspection and final product sampling, packaging, storage, and shipment at PCI’s Bedford, New Hampshire site. The role primarily ensures timely product inspections, including Acceptable Quality Limits (AQL) and Bulk AQL, maintains the final product retain program, and supports visual inspection from a quality assurance and compliance perspective. The specialist partners with QA Operations, Manufacturing, Visual Inspection, Materials Management, and Project Management teams. The position is scheduled for the first shift, Monday through Friday, from 8:30 a.m. to 5:00 p.m., and reports to the Sr. Director, Quality.

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 working with international regulations such as ICH.
Knowledge of and 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, 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 toward colleagues.
Resilience through operational and organizational change.
Excellent interpersonal skills and ability to communicate well orally and in writing.
Proficiency in Microsoft Office, including Word and Excel.

Nice To Haves

Bachelor’s degree in a relevant scientific field.
At least five 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 and communicate factors that may affect scheduled activities.
Inspect final packaged lots and bulk packaging, perform final product disposition functions, conduct AQL inspections, and handle final product sampling and retains.
Create, review, and approve final product shipper and vial labels.
Perform annual inspections of final product retains and support the final product retain program.
Ensure training and qualification status remains current.
Review batch records and supporting GMP documentation.
Write or revise Standard Operating Procedures and maintain, evaluate, and improve processes and procedures.
Perform Media Fill inspections.
Support maintenance of final product reject inventory, the defect library, and Visual Inspection Qualification kits.
Initiate and own Quality Systems activities, including Events, Deviations, and CAPAs.
Train and/or qualify new and less experienced staff members.
Work with Visual Inspection, Project Management, Materials Management, and QA teams to schedule and prioritize activities.
Support leadership in site harmonization efforts related to Visual Inspection and QA Operations.
Represent QA-Visual Inspection on internal project teams and collaborative activities, including scheduling, run readiness, and batch disposition meetings.
Assist QA-Visual Inspection team members with scheduling and prioritizing daily activities.
Perform other duties as assigned.