Catalent, Inc
Specialist III - Quality Assurance
Madison, WI · Mid
Sponsorship not specifiedDetected 6 days ago
Clinical Trials
About the role
- Accountable for review of Master Batch Production Records and material specifications for prepared solutions and columns.
- Responsible for oversight of the control and management of Cell Bank inventory.
- Provides review and approval of protocols and associated executed reports supporting Manufacturing operations, including media process simulations.
Responsibilities
- Responsible for representing Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution.
- 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 6 years related experience.
- Master's Degree in STEM discipline with minimum of 8 years related experience.
- Bachelor's Degree in STEM discipline with minimum of 10 years related experience.
- Associates Degree in STEM discipline with minimum of 14 years related experience.
- 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
Company info
- This is a unique opening to join a small, fast-growing business, backed by a global public company.
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