Qa Supervisor - Labeling/Packaging

The Quality Assurance Supervisor will support the Agenus West Christie Ave (Emeryville) Labeling and Packaging operations, Clinical Labeling and Packaging operations (CMO/CRO), and the associated Quality Systems (Deviation, CAPA, Change Control etc.). The position will support the master batch record and SOP development for Labeling and Packaging operations, review of deviations and executed batch records, and disposition onsite and CMO labeled/packaged drug product. The Supervisor will report to the Associate Director, Quality Assurance, and partner with Global QA for Quality System initiatives, as directed.

• QA and GMP compliance for all aspects in support of clinical and commercial (future) operations

• Site Quality Systems Management: CAPA, Change Control, Deviations, Investigations, Risk Assessment, and Vendor Change Notification with emphasis on labeling/packaging operations

• Onsite and CMO finished (labeled/packaged) drug product lot batch record QA review and disposition.

• Quality Assurance Approver for site SOPs and other GMP documentation associated with labeling/packaging operations

• Site QA Representative with Agenus Corporate for Corporate QA SOPs development/revision, as directed

• Support internal, partner and health authority audits, as needed

• Support/review applicable regulatory submissions, as needed

Qualifications:

• Minimum of 5 years in Quality Assurance, preferably in the biologics field

• Experience in reviewing cGMP/GLP related documents (SOPs, protocols, batch records, technical reports, etc.)

• Experience with labeling/packaging operations preferred

• Experience with supervision and training of personnel preferred

• Working knowledge of GMP principles with respect to FDA and EMA regulations

• Working knowledge and technical understanding of the manufacture and testing of biologics

• Experience working with contract manufacturing and testing facilities (domestic and global)

Education Requirements:

• BS (or equivalent) in a scientific related field with a minimum of 7 years' experience in the pharmaceutical/biotech industry