GMP QA Contractor
Precision Life Sciences
- Hayward, CA
AD GMP QA
- 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).
PRECISION LIFE SCIENCES
Sunday, November 20, 2022