Catalent Pharma Solutions
Biologics
SeniorAssociateQualityAssuranceOperations(2ndShift)
“Senior Associate - Quality Assurance Operations (2nd Shift) at Catalent Pharma Solutions. Skills: Quality Assurance Operations, process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement. execution of the QA on the Floor program. routine walkthroughs of the Manufacturing Area”
What You'll Achieve.
ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements; safeguards all systems, processes, and actions to ensure regulatory compliance; providing high quality drug products for our clients and their patients
Industry & Context.
troubleshooting when problems arise
100% on-site, Wed-Sat 2pm-12pm
What They're Looking For.
Must Have
Master's degree in STEM discipline with minimum of 0 years related experience, Bachelor's Degree in STEM discipline with minimum of 3 years related experience, Associates Degree in STEM discipline with minimum of 6 years related experience, High School Diploma with a minimum of 7 years related experience
What You'll Do.
execution of the QA on the Floor program
routine walkthroughs of the Manufacturing Area
direct quality support for routine manufacturing operations
issuance of controlled documents for production
review of documentation
release of produced solutions and columns
inspection of final product containers
shipment of finished products
review of facility and equipment records
control and management of Cell Bank inventory
notification of potential quality or regulatory issues
maintain the product quality and site CGMP compliance
Files and maintains controlled documents
How You'll Work.
Team & Collaboration
partnering with manufacturing on Quality best practice implementation
Process & Methodology
project review for accuracy and compliance
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