GMP QA Contractor

Precision Life Sciences - Hayward, CA


Job Responsibilities

  • Responsible for providing QA oversight and support for batch disposition, quality record ownership, and management of other QA activities. Provide input in a manner that is phase-appropriate and ensures necessary quality principles are appropriately applied.
  • Collaborate with internal and external stakeholders on deviation investigations, CAPA plans, change controls, shelf life extensions, and revisions to documentation.
  • Review and approve master batch records, PFDs, and other technical documents originating from PD or MSAT.
  • Clearly and effectively communicate Quality decisions and participate in cross-functional forums as a Quality representative.
  • Manage operations at CMOs as a QA lead and ensure procedures at CMO align with industry standards. Represent Arcus QA in external meetings.
  • Support audits and inspections as needed.
  • Support QA initiatives and projects as assigned.
  • Review technical protocols/reports and raw data as assigned.
  • Assist with regulatory submissions and RTQs as needed.
  • Champion Quality culture within the organization while fostering a collaborative environment with both internal and external partners.

Qualifications (including Knowledge & Skills)

  • Bachelor’s degree in Life Sciences with 12+ years, Master’s degree with 10+ years, or Ph.D. with 7+ years in the biotech or pharma industry with a strong quality background
  • Familiarity with FDA, EMEA and other international guidelines pertaining to pharmaceuticals.
  • Experience managing quality aspects of development/validation, manufacturing, and testing activities at CDMOs or CTLs required.
  • Excellent analytical skills and a strong technical background on antibody process development, validation, and testing strongly desired.
  • Excellent written and verbal communication skills.
  • Excellent organizational skills and ability to independently manage multiple projects/tasks based on shifting priorities.
  • Highly proficient with various Microsoft and other computerized systems (Word, Outlook, Excel, PowerPoint, Visio, Veeva, Smartsheet, etc).



Posted On: Sunday, November 20, 2022

Apply to this job