Manager II, Quality Assurance

Let’s talk about some of the key responsibilities of the role:

Reporting to the Associate Director, Quality Assurance, 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.

Factors for Success:

• 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.
• Analyze and trend data
• Author Annual Product Reviews (APRs)
• 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

Required Skills, Education, and Experience:

• 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
  • Charts and Graphs
• ASQ Certification Preferred

A Few Other Details Worth Mentioning:

• The position will be based in our beautiful Irvine office, complete with a courtyard, snacks, drinks, and occasional catered meals.
• Hybrid position with two remote working days per week
• 10% of travel may be required

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $116,200 - $162,800 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://alliantbenefits.cld.bz/25tarsusbenesnap.

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