Michael Funk

• Led teams of up to 7 personnel, supervising daily performance as well as training and improvement plans.
• Mentored junior staff members, providing guidance on professional development opportunities and career progression paths.
• Leads the review and approval of quality system records (i.e. deviations, laboratory events, change management, qualification/validation); ability to coach and train team and cross-functional colleagues to ensure cGMP compliance to these specific areas.
• Manages direct reports in the review of quality system records, oversight of stability programs, and oversight of analytical equipment activities. Prepares and manages team schedule for this activity and tracks to ensure timelines are met

· Analytical review of product and raw material test data from contract laboratories and in-house testing.

· Oversight of laboratory equipment, ensuring cGMP and data integrity compliance.

· Quality Control lead for deviations and laboratory investigations.

· Represented QC on several company wide teams, including improving documentation and training for non-conformances as well as inventory and labeling of laboratory equipment.

· Participated in internal and external audits as prep room manager, subject matter expert, document retrieval and review, and scribe.

· Identify, set up, and maintain quality requirements by reviewing regulations and implementing guidelines and standards.

· Assess quality compliance by verifying and reviewing documentation and process changes.

· Build and maintain a corrective and preventive action system.

· Generate and update documentation and manufacturing procedures to comply with ISO 13485 regulations.

· Management representative for external audits.

· Manage the quality control and quality assurance aspects of the company.

· Generation, revision, and oversight of all standard operating procedures.

· Obtain and maintain licensing and certification for the following; FDA (Drug Manufacturing/GMP), ISO 9001:2000, Department of Justice – Controlled Substances, City of San Jose Water Department.

· Oversight of quality control functions as they pertain to incoming and final product release testing.

· Handling of customer product complaints related to quality issues.

· Managed the Quality Control group responsible for the release and stability testing of GVAX bulk and final product.

· Coordinated work with multiple contract laboratories that perform safety testing on bulk and final product; including shipping, weekly teleconferences to ensure scheduling and resolution of issues, and review of final reports.

Quality Control representative in multi-group meetings ranging from internal assay transfers to daily follow up meetings for Manufacturing, QA, and Final Product testing.

· Lead role in the reconstruction of the commercial stability program.

· Creation and implementation of annual stability reports used in filing both the annual report to the FDA and the company’s annual product review.

· Quality Control lead and active participant in numerous FDA inspections and internal audits.

· Manage and participate in the creation of, revisions to, and implementation of Standard Operating Procedures to continuously improve the procedures utilized by the Quality Control group.

· Lead the stability group to ensure proper scheduling and completion of release and stability testing, quarterly stability reports, entering and merging incoming release and stability data.

· Conduct release and stability testing of API and drug product

· Planning, preparation for, and startup of a new Central Lab Services facility.

Supervision of media, reagent, and glassware preparation for Research and Development departments