Job Description
- Job Description:
- Serve as the GMP QA partner for the development programs, from early phase through validation
- Review and approve analytical method transfer and validation protocols and final reports for Drug Substance and Drug Product
- Review and approve analytical methods and specifications, stability protocols and reports
- Perform review and approval of analytical and microbiological testing data for Drug Substance, Drug Product Intermediates and Drug Product
- Perform batch record review and disposition related activities for Clinical and Commercial Supplies
- Review and approve Master Batch Records, review CMO change controls and provide quality impact assessments relating to proposed changes
- Coordinate Quality Events (Laboratory Investigations, Deviations, CAPAs) with CMOs and escalate to QA management as appropriate
- Oversee QA aspects of API, Drug Product and Packaging and Labeling Operations for Crinetics products
- Represent QA in internal and external team meetings
- Support QA team on internal and external GMP audits
- Perform and/or review impact assessments and risk assessments
- Write and review Standard Operating Procedures
- Write internal investigations, as applicable; review external, CMO investigations as assigned
- Compile metrics of Batch Disposition, deviations, CAPAs, as applicable
- Perform vendor audits as assigned and support vendor lifecycle activities
- Requirements:
- Bachelor’s degree in chemistry, engineering or other scientific discipline
- 7 years of relevant experience in a regulated GMP environment with 2 years of supervisory/leadership experience
- Demonstrated knowledge of FDA/EMA/ICH standards and regulations
- Demonstrated knowledge of Risk Assessment and Root Cause Analysis (5 WHYs, FMEA)
- Relevant analytical experience, including understanding and working knowledge of chromatography and chromatographic methods (i.e. HPLC, GC)
- Working knowledge of relevant manufacturing and analytical testing equipment and instrumentation
- Demonstrate ability to effectively organize, prioritize and work in a fast-paced environment
- Demonstrate ability to function individually and in a team environment
- MS Office, ERP systems
- Benefits:
- health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
- 20 days of PTO
- 10 paid holidays
- winter company shutdown
- discretionary annual target bonus
- stock options
- ESPP
- 401k match
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