Quality Assurance Specialist

4 weeks ago


Palo Alto, California, United States Scilex Holding Full time
About the Role

Scilex Holding Company is seeking a highly skilled Quality Control Consultant to support the development and commercialization of non-opioid pain management products. The ideal candidate will have a strong background in analytical development and quality control/analytical testing of commercial or late-stage clinical small molecule or biological products.

Key Responsibilities
  • Support analytical development and quality control/analytical testing of commercial or late-stage clinical small molecule products, drug substance, raw materials, packaging components, manufacturing equipment qualifications at existing CDMO/CMO or method a new CDMO/CMO.
  • Review/support CDMO/CMO manufacturing services agreements, support quality agreements, RFP from analytical testing perspectives.
  • Support testing for analytical method development and method validation/MV for commercial and clinical products at CMO/CDMO.
  • Support testing for FMEA, process performance qualification/PPQ, continuous process verification/CPV, equipment qualification, site registration, cleaning studies/validation, shipping studies/validation, etc. for commercial and clinical products at CMO/CDMO.
  • Author/review/approve from analytical testing perspectives of analytical method development, method validation protocols/reports, PV/PPQ, CPV, MBRs and EBRs and final product disposition, any CMC development protocols/reports, qualification/validation protocols/reports, stability protocols/data/reports, and release/stability analytical method development, method validation and testing for drug substances present in commercial and clinical products at CMO/CDMO.
  • Ensure GMP compliance from analytical testing perspectives for raw materials and packaging components required for manufacturing of drug substances and commercial and clinical products.
Requirements
  • Minimum bachelor's degree in analytical chemistry, biochemistry, biology, chemical sciences or in a relevant scientific discipline or equivalent.
  • Minimum of 8 to 12 + years of analytical development and quality control for Commercial Products or Late-Stage, Phase 3 Clinical Product in Pharmaceutical or Biologic Companies.
  • Experience in Quality Control/Analytical Testing for GMP manufacturing of commercial products and/or late stage/Phase 3 clinical pipeline is a must.
  • Experience in analytical method development, method qualification/method validation, release and stability testing, investigations, deviations, change controls, CAPA and OOS/OOT for commercial products and clinical pipeline is a must.
What We Offer

Scilex Holding Company offers a competitive salary and benefits package, as well as opportunities for professional growth and development.



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