Catalent Pharma Solutions
Pharma
QAInspector-2ndShift
Neural analysis suggests this role is
optimal for Mid+ candidates.
“QA Inspector - 2nd Shift at Catalent Pharma Solutions. Skills: Quality Assurance, cGMP, auditing, documentation review. process monitoring and auditing of packaging operations. real-time batch documentation review”
What You'll Achieve.
improve the ‘right-first-time’ performance of the operation
Industry & Context.
analytical thinking; sound judgment
100% on-site, Comfortable being on your feet and moving between multiple warehouse areas, frequently in cold environments
What They're Looking For.
Must Have
minimum of 2 years of quality or manufacturing experience within a GMP environment, written and verbal communication skills, Effective interpersonal skills and ability to work collaboratively in a team environment, analytical thinking and sound judgment, Ability to quickly learn and apply QA auditing techniques, Ability to stand and/or sit for long periods of time, Ability to occasionally lift 0-25 pounds, Willingness to work overtime, Willingness to work in cold environments
Nice to Have
Bachelor’s degree, minimum of 1 year of quality or manufacturing experience within a GMP environment, Proven track record of monitoring/auditing for quality assurance, identifying potential efficiencies in a production environment, Proficient computer experience with MS Office and inventory management systems is a plus, has the ability to thrive in a dynamic environment with shifting priorities
What You'll Do.
process monitoring and auditing of packaging operations
real-time batch documentation review
monitoring of adherence to cGMP
training on cGMP where necessary
supporting actions for resolution of deviations and investigations
packaging room and equipment set up
equipment verification
routine packaging operations
room and equipment cleaning activities
identify opportunities to improve the ‘right-first-time’ performance of the operation
Ensure SOPs and cGMP requirements are consistently followed during packaging operations
Verify and reconcile materials before/after production
Inspect and release packaging rooms
Document activities in applicable logbooks
review production logbooks and batch records for GMP and documentation accuracy
Support mechanics with Operational Verifications (OVs)
Review Production and QA Protocols before job start
perform/document hourly QA inspections per SOP and protocol requirements
Monitor adherence to GMP standards during packaging
ensure batch documentation aligns with inventory system entries and printed labels
Review environmental monitoring outputs (temperature
ensure clean storage rooms meet approval criteria
and clean storage walkthroughs
verify GMP document shift activities in QA turnover logs
monitor and maintain production rates
labor hours and downtime
How You'll Work.
Team & Collaboration
collaborate with Production, Materials Management, and Project Management to resolve discrepancies; Partner with cross‑functional teams on deviations, investigations, and support sampling/testing requests, equipment parts review, and customer audits; work collaboratively in a team environment
Communication Scope
written and verbal communication skills
Full Job Description
**Quality Assurance Inspector** **(Production)** **Position Summary** * **Work Schedule: Monday – Friday, 3:45pm - 12:15am** * **100% on-site** Catalent’s 206,878-square-foot Philadelphia-area facility serves as the global Center of Excellence for Clinical Supply Packaging, offering GMP secondary packaging and clinical labeling services. The site provides manual to fully automated packaging solutions, including temperature-controlled options for sensitive products. Come and be part of a team that delivers industry-leading quality and innovation. Catalent Pharma Solutions in Philadelphia is hiring a Quality Assurance Inspector, Production and this position reports to the Quality Supervisor. The Quality Inspector is responsible for process monitoring and auditing of packaging operations, the duties including real-time batch documentation review, monitoring of adherence to cGMP, training on cGMP where necessary, and supporting actions (if required) for resolution of deviations and investigations. The scope of work will cover packaging room and equipment set up, equipment verification, routine packaging operations, line clearances, room and equipment cleaning activities. The Quality Inspector will identify opportunities to improve the ‘right-first-time’ performance of the operation and will manage those opportunities to implementation and improvement, in partnership with Production personnel. **The Role** * Ensure SOPs and cGMP requirements are consistently followed during packaging operations, including real-time auditing and monitoring. * Verify and reconcile materials before/after production and collaborate with Production, Materials Management, and Project Management to resolve discrepancies. * Inspect and release packaging rooms, confirming proper cleaning and material clearance per GMP expectations. * Document activities in applicable logbooks and review production logbooks and batch records for GMP and documentation accuracy. * Support mechanics with Operational
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