Catalent Pharma Solutions
Biologics
SeniorAssociate-QualityAssuranceOperations(2ndShift)
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“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
Full Job Description
**Senior Associate I - Quality Assurance Operations (2nd shift)** **Position Summary:** * **Work Schedule:** Wed-Sat 2pm-12pm * 100% on-site Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast growing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer’s. **Catalent Pharma Solutions in Madison, WI is hiring a Senior Associate I - Quality Assurance Operations.** The Quality Assurance department is responsible for all aspects of the quality assurance functions at Catalent, Madison. The department’s primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. This includes systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review for accuracy and compliance, and material disposition. Quality Assurance safeguards all systems, processes, and actions to ensure regulatory compliance, which is essential in providing high quality drug products for our clients and their patients. **The Role:** * Accountable for execution of the QA on the Floor program. * Performs routine walkthroughs of the Manufacturing Area partnering with manufacturing on Quality best practice implementation and troubleshooting when problems arise. * Provides direct quality support for routine manufacturing operations. * Responsible issuance of controlled documents for production, including Batch Production Records, Product Labels and forms. *
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