Catalent, Inc
Specialist I - Quality Assurance Operations, Data Review
Madison, WI
Sponsorship not specifiedDetected 2 days ago
ComplianceExcelAuditingClinical TrialsGMPFDA RegulatoryCommunication
About 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.
Responsibilities
- Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart, and lung diseases as well as Alzheimer's.
- The Quality Assurance Operations group has oversight of the manufacturing areas, including process technology transfer, master batch record review and approval, on-the-floor support, product disposition, and shipping.
Requirements
- Doctorate Degree in STEM discipline with minimum of 0 years related experience.
- Master's Degree in STEM discipline with minimum of 4 years related experience.
- Bachelor's Degree in STEM discipline with minimum of 6 years related experience.
- Associates Degree in STEM discipline with minimum of 10 years related experience.
- Ability to use Excel, Word, and other office systems.
- Prior work experience with quality management software such as TrackWise® or ComplianceWire®.
- Let us help you finish your degree or start a new degree!
Compensation
- Defined career path and annual performance review and feedback process
Benefits
- 152 hours of PTO + 8 paid holidays
- Medical, dental and vision benefits effective day one of employment
- Tuition Reimbursement
- Working for Catalent Biologics is an opportunity to join an entrepreneurial team.
- This is a unique opening to join a small, fast-growing business, backed by a global public company.
Apply directly at Catalent, Inc →Create a free account for alerts like thisView Catalent, Inc immigration profile
This listing is sourced directly from Catalent, Inc's careers page and normalized into a canonical job model.