What are the responsibilities and job description for the Senior QC Specialist position at Medix?
About the Company
Join a newly-established in-house QC team at a growing biologics company in Redwood City, CA. Collaborate with teammates to continue developing and building out the new in-house QC testing lab. As a senior team member, in addition to conducting QC analysis benchwork, contribute via QC protocol development, overseeing outsourced QC testing, review of method transfer / method qualification, leading QC-related QMS activities, and more.
Responsibilities
- Serve as a team proficiency expert for ddPCR (droplet digital PCR) and other molecular based and cell based QC assays for batch release, stability testing, and product characterization purposes.
- Review internal GMP analytical testing and method qualification.
- Collaborate with Analytical Development on assay development and troubleshooting.
- Provide oversight for external QC testing at third party labs / CMO.
- Develop QC protocols and SOPs as needed.
- Lead Lab deviation investigations, CAPAs, change controls and other QMS activities.
- Coordinate lab equipment qualification and validation activities.
Qualifications
BS degree and 8 years, MS degree and 6 years, or PhD and 4 years of Quality Control or Analytical Development experience with Biologics.
Required Skills
Preferred Skills
