Catalent Biologics
Biologics
SeniorAssociate-QualityAssuranceOperations,DataReview
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“Senior Associate - Quality Assurance Operations, Data Review at Catalent Biologics. Skills: Quality Assurance, Data Review, Regulatory Compliance. Maintain and enhance Quality System. Ensure compliant preparation of quality control”
Industry & Context.
What They're Looking For.
Must Have
Master's degree STEM 0 years experience, Bachelor's Degree STEM 3 years experience, Associates Degree STEM 6 years experience, High School Diploma 7 years experience
What You'll Do.
Maintain and enhance Quality System
Ensure compliant preparation of quality control
Ensure compliant execution of quality control
Review analytical data
Review microbiology data
Review documentation for accuracy
Review documentation for completeness
Review documentation for compliance
Report unusual testing results
Report out-of-specification testing results
Review supporting documentation
Ensure traceability to raw data
Verify reagents within acceptance range
Verify standards within acceptance range
Verify equipment within acceptance range
Ensure analysts follow SOPs
Ensure analysts follow CGMP regulations
Work with analysts for corrections
Provide guidance to analysts
Notify Management of quality issues
Notify Management of regulatory issues
Full Job Description
**Senior Associate I - Quality Assurance Operations, Data Review** **Position Summary:** · **Work Schedule:** M-F 8am-5pm · 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, Data Review.** 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:** · Responsible for maintaining and enhancing the effectiveness of the Quality System through ensuring compliant preparation and execution of quality control operations. · Review analytical and microbiology data and documentation including raw data, test methods, protocols and reports for accuracy, completeness, and compliance in a timely manner · Review and report unusual or out-of-specification testing results · Rev
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