Manager, Quality Control
Ensure timely delivery schedules of drug substance by conducting raw data review and preparing certificate of analysis describing test results that meet Affymax specifications. Prepare protocols and reports describing qualification and characterization of reference standards and materials. Perform out of trend, deviation investigations and change controls interfacing with contract testing laboratories and/or Quality Assurance. Responsible for active pharmaceutical ingredient and drug product stability testing activities such as stability data review and stability database management. Position reports to Quality Control Director.
- Coordinate outsourced testing of stability and release samples.
- Coordinate samples to contract laboratories from manufacturing sites, maintaining the chain of custody.
- Insure samples are tested according to protocols and specifications.
- Review data generated at contract laboratories.
- Assist in the preparation of protocols, reports and test methods generated in contract laboratories.
- Work collaboratively with contract testing facilities to insure compliance (conducting and closing investigations, deviations, etc).
- Ensure that release and stability testing, deviations, investigations and change controls generated at Affymax, contract testing laboratories and manufacturing sites are consistent with cGMP and CFR regulations.
- Manage the investigation of out of specifications results by participating in the planning, execution, and report writing process of any investigation initiated internally or by contractors
- Prepare and implement change control for analytical methods, protocols, and specifications
- Maintain QC inventory of reference materials and reference standards and assure replacements and cross-over studies when appropriate and re-stocking levels are reached. .Ensure reference standards/materials are recertified and COAs reissued and distributed to end users. Request synthesis of reagents prepared in-house.
- Write, review and approve SOPs, test methods, specifications, protocols, reports, shipment of samples and other documentation related to QC and analytical testing
- Prepare stability sections for regulatory/QC documents in support of regulatory fillings including annual product reviews, annual stability reports and annual reports.
- Participate and respond to in internal audits.
- Present data at group meetings and provide improvement suggestions based on data presented.
- M.S. degree in Chemistry, Biochemistry, Pharmaceutical science or related field with a minimum of five (5) years of experience in bio/pharmaceutical industry and at least two (2) years supervising QC activities or B.S. degree with a minimum of seven (7) years of experience in bio/pharmaceutical industry and at least two (3) years supervising QC activities.
- Knowledge of cGMP/ICH/FDA regulations.
- Effective oral and written communication skills.
- Previous experience in working with external parties (CMOs, Contract Labs) is preferred.