Catalent Biologics
Biologics
SeniorAssociateQualityAssuranceOperations,OntheFloor
“Senior Associate - Quality Assurance Operations, On the Floor at Catalent Biologics. Skills: Quality Assurance Operations, Regulatory Compliance, Documentation Review. Execute QA on the Floor program. Perform routine walkthroughs of Manufacturing Area”
Industry & Context.
Troubleshooting
What They're Looking For.
Must Have
Master's degree STEM 0 years experience, Bachelor's Degree STEM 3 years experience, Associate's Degree STEM 6 years experience, High School Diploma 7 years experience
What You'll Do.
Execute QA on the Floor program
Perform routine walkthroughs of Manufacturing Area
Partner with manufacturing on Quality best practice
Provide direct quality support for manufacturing operations
Issue controlled documents for production
Review documentation for production of solutions
Review documentation for production of columns
Perform release of produced solutions
Perform release of produced columns
Assist with inspection of final product containers
Support shipment of finished products
Review facility records for GMP operations
Review equipment records for GMP operations
Control and manage Cell Bank inventory
Notify Management of potential quality issues
Notify Management of potential regulatory issues
Perform tasks to maintain product quality
Perform tasks to maintain site CGMP compliance
Support tasks to maintain product quality
Support tasks to maintain site CGMP compliance
File controlled documents
Maintain controlled documents
How You'll Work.
Team & Collaboration
Partnering with manufacturing
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