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Manager II – Quality Assurance
| Company | Tarsus Pharamceuticals |
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| Location | Irvine, CA, USA |
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| Salary | $116200 – $162800 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Senior, Expert or higher |
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Requirements
- Minimum of 8 years’ experience in the Pharmaceutical Industry
- Minimum of 5 years’ experience in Pharmaceutical Quality Assurance
- Bachelor’s Degree in a scientific field preferred
- Attention to detail
- Strong computer skills
- Knowledge of Microsoft Office Systems
- ASQ Certification Preferred
Responsibilities
- Review and process manufacturing Deviations and Laboratory OOS
- Review manufacturing-related Change Controls within Tarsus’ established QMS system
- Author Annual Product Reviews
- Analyze and trend analytical data
- Approval of Certificates of Analysis
- Manufacturing batch record review
- Product disposition
- Review and approve Vendor Change Controls
- Review and approve vendor documents including Master Batch Records/Master Packaging Records
- Review product and material Specifications
- Review and approve Deviations and Out of Specification (OOS) investigations
- Author and revise relevant Quality Assurance Procedures
- Review proposed batch records and manufacturing-related process validation protocols
- Conduct Internal Audits
- Review and approve Test Record Review Form and Certificate of Analysis
- Review and approve executed manufacturing batch records and packaging batch records
- Complete Final Product Disposition Forms and Certificate of Compliance
- Participate in internal Operations
- Collaborate in Meetings/discussions with Tarsus’ manufacturing partners and testing
Preferred Qualifications
- Bachelor’s Degree in a scientific field preferred
- ASQ Certification Preferred
