QA Operations Specialist I – Visual Inspection

PCI Pharma Services•Bedford, NH

1d•Onsite

About The Position

The QA Operations Specialist I – Visual Inspection supports activities associated with visual inspection and final product sampling, packaging, storage, and shipment at PCI’s Bedford, New Hampshire site. The role primarily maintains timely product inspection, including Acceptable Quality Limits (AQL) and Bulk AQL, and the final product retain program, while supporting visual inspection from a quality assurance and compliance perspective. The specialist partners with QA Operations, Manufacturing, Visual Inspection, Materials Management, and Project Management. The position supports inspection and disposition of packaged and bulk lots, sampling and retains, labeling and shipment activities, GMP documentation review, quality systems, staff training, scheduling, and continuous improvement. This role reports to the Sr. Director, Quality and works a first shift schedule Monday through Friday, 8:30 a.m. to 5:00 p.m.

Requirements

High school diploma required.
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, checked annually; ability to see all colors and visually discern product specifications across multiple products.
Ability to work in a dynamic, fast-paced environment.
Honesty, integrity, respect, and courtesy 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 2 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 for 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; support final product disposition, AQL inspection, sampling, and retains.
Create, review, and approve final product shipper and vial labels.
Conduct annual inspection of final product retains and support maintenance of the final product retain program.
Ensure training and qualification status is current and in good standing.
Review batch records and supporting GMP documentation.
Write or revise Standard Operating Procedures.
Evaluate current processes and procedures and drive continuous improvement efforts.
Conduct 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.