Reporting to the Associate Director, Quality Assurance, the Manager II, Quality Assurance, is responsible for the review and processing of manufacturing Deviations and Laboratory OOS, and review of manufacturing-related Change Controls within Tarsus’ established QMS system. This role will also be responsible for authoring Annual Product Reviews, analyzing and trending analytical data, approval of Certificates of Analysis, manufacturing batch record review and product disposition.
Let’s talk about some of the key responsibilities of the role:
- Review/Approve Vendor Change Controls
- Review/Approve vendor documents including Master Batch Records/Master Packaging Records
- Review Specifications
- Review/Approve Deviations/OOS
- Analyze and trend data
- Author Annual Product Reviews
- Author/Revise relevant Quality Assurance Procedures
- Review new proposed master manufacturing records and manufacturing-related process validation protocols
- Review/Approve Test Record Review Form and Certificate of Analysis
- Review/Approve executed manufacturing batch records and packaging batch records
- Review/Approve/Complete Batch Record Review Form (Batch Disposition)
- Complete Final Product Disposition Form and Certificate of Compliance
- Participate in internal Operations
- Participate in Meetings/ discussions with Tarsus’ manufacturing partners and testing laboratories
Factors for Success:
- Bachelor’s Degree preferred, plus 8+ years’ experience in the Pharmaceutical Industry
- 5+ years experience in Pharmaceutical Quality Assurance
- Strong attention to detail
- Proficient technical skills across multiple platforms
- Strong knowledge of Microsoft Office Systems
- Charts and Graphs
- ASQ Certification Preferred
A Few Other Details Worth Mentioning:
- The position is hybrid and will be based in our beautiful Irvine office three days per week, complete with a courtyard, snacks, drinks, occasional catered meals, and pet-days.
At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $120,000 - $168,000 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://eb.alliant.com/26tarsusbenefitssnapshot.
#LI-Hybrid
Tarsus Pharmaceuticals, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
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Tarsus Pharmaceuticals Irvine, California, USA Office
15440 Laguna Canyon Rd, Irvine, CA, United States, 92618
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