Catalent Pharma Solutions
Pharma
QualityAssuranceInspector
“Quality Assurance Inspector at Catalent Pharma Solutions. Skills: Quality Assurance, cGMP Compliance, Process Improvement. Perform inspection and release of components. Inspect clinical and commercial drug products”
What You'll Achieve.
Ensuring SOPs and cGMP are being followed; Verify and inspect incoming materials; Inspect and release clinical and commercial drug products and components per customer specifications and Catalent SOPs; Inspect and release shipping and distribution materials by verifying paperwork, picked items, and randomized containers for protocol compliance; Inspect and release materials designated for destruction by reviewing associated documentation and materials; Inspect and release clinical labels by comparing to approved proofs or label copy requests; Maintain and report departmental metrics; Support walkthrough audits of Supply Chain areas for GMP compliance; Support deviation investigations and process improvements
Industry & Context.
analytical thinking; sound judgment
100% on-site, Ability to stand and/or sit for long periods of time, Occasionally lift 0-25 pounds, Willingness to work overtime, Frequently work in cold environments, track, monitor and maintain production rates, labor hours and downtime
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, Ability to work collaboratively in a team environment, analytical thinking, sound judgment, Ability to thrive in a dynamic environment with shifting priorities, Comfortable being on your feet and moving between multiple warehouse areas, Ability to quickly learn and apply QA auditing techniques, Ability to stand and/or sit for long periods of time, Occasionally lift 0-25 pounds, Willingness to work overtime, Frequently work in cold environments
Nice to Have
Bachelor’s degree, Minimum of 1 year of quality or manufacturing experience within a GMP environment, Proficient computer experience with MS Office, inventory management systems
What You'll Do.
Perform inspection and release of components
Inspect clinical and commercial drug products
Inspect shipping and distribution materials
Inspect materials designated for destruction
Inspect clinical labels
Review BMS and chart recorder printouts
Inspect retain samples
Maintain and report departmental metrics
Support walkthrough audits
Support deviation investigations
Perform additional sampling or testing
Participate in customer audits
Complete required documentation
Support other tasks assigned
How You'll Work.
Team & Collaboration
Collaborate with Quality and Project Management to resolve discrepancies; Partner with Supply Chain personnel, Project Management, and Operations for process improvements
Communication Scope
written and verbal communication skills
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