About the job
As a pivotal member of our Quality Assurance team, the Manager II, Quality Assurance will report directly to the Associate Director of Quality Assurance. This crucial role entails the meticulous review and management of manufacturing deviations and laboratory out-of-specification (OOS) reports, along with the assessment of manufacturing-related change controls in alignment with Tarsus’ Quality Management System (QMS). The Manager II will also take charge of authoring Annual Product Reviews, interpreting and trending analytical data, approving Certificates of Analysis, reviewing manufacturing batch records, and determining product disposition.
Key Responsibilities:
- Evaluate and authorize vendor change controls.
- Scrutinize vendor documents such as Master Batch Records and Master Packaging Records.
- Review product specifications for compliance.
- Assess and approve deviations and OOS reports.
- Conduct data analysis and trend evaluations.
- Author Annual Product Reviews to ensure product integrity.
- Revise and author Quality Assurance Procedures as necessary.
- Examine new master manufacturing records and process validation protocols.
- Review and approve test records and Certificates of Analysis.
- Evaluate executed manufacturing and packaging batch records.
- Complete batch record review forms for product disposition.
- Finalize product disposition forms and Certificates of Compliance.
- Engage in internal operations discussions.
- Collaborate with Tarsus’ manufacturing partners and testing laboratories.

