We have a current opportunity for a Clinical Quality Associate on a 6-month contract basis. The position will be based in Novato, CA. We are only able to place candidates on a W2 basis. For further information about this position please apply.
Location: Novato, CA
Contract length: 6 months on W2, opportunity to extend
Duties: This position reports to the Director / Supervisor/ Manager/ Senior Manager, Clinical Quality Operations and is responsible for quality oversight for processes relating to the development, manufacture and testing of clinical material. The responsibilities in the role include the following:
- Review of GMP documentation from Pilot Plant, CDMOs, Analytical Sciences, including log books, batch records and test records.
- Issuance of Batch Records for clinical production Review and approval of procedures and batch records related to early phase programs(Quality, Pilot Plant, Analytical Sciences, other areas).
- Review and approval of quality system records including change requests, deviations and CAPA for Technical Development (i.e. Pilot Plant, Analytical Sciences, Process Development).
- Oversee manufacturing and QC adherence to company policies/procedures, regulatory licenses, industry standards, and GMP regulations.
- Minimum 3 years of experience in a Quality/Compliance/Regulatory setting
- Sound knowledge of cGMPs and equivalent industry regulations
- Prior experience with oversight of manufacturing or testing operations
- Proficiency with computer systems - Microsoft Office Suite Proficiency with database use: For example, Veeva or other QMS, Benchling or other ELN, LIMS, Oracle or other ERP preferred