Manager II, Quality Assurance (Commercial)

Role Summary

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. This is a hybrid role based in Irvine, CA (three days per week in the office).

Responsibilities

• 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

Qualifications

• 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
• Preferred: ASQ Certification

Education

• Bachelor’s Degree preferred