Catalent, Inc
Specialist I - Quality Assurance
Madison, WI
Sponsorship not specifiedDetected 1 day ago
ComplianceExcelAuditingClinical TrialsGMPFDA RegulatoryCollaboration
About the role
- Accountable for the compliance and effectiveness of the Supplier and Material Quality Assurance programs.
- Schedule and conduct audits of suppliers and vendors in accordance with site policies and procedures.
- Evaluate audit results and follow up on any outstanding issues/actions.
Responsibilities
- Responsible for collaboration with Catalent sister sites and suppliers to draft and maintain Quality Agreements.
- Responsible for collaboration with internal Catalent stakeholders to support the Supplier Quality Assurance team in leading corrective action associated with material and supplier quality issues.
- Develop and conduct training to support consistent and accurate execution of the supplier and material quality controls.
- 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.
- The Quality & Compliance group has oversight of internal and client audits as well as regulatory agency inspections, compliance and regulatory support initiatives, and process validation activities.
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®.
- Ability to independently apply CGMPs to everyday work.
- 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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