Primary Duties
1. Oversees microbiological, chemical, and physical inspection testing functions. Recruits and develops team members, establishes resources and determines actions necessary to accomplish quality control objectives.
2. Reviews and approves test results. Supports release of final product, raw materials, components, and intermediate products. Supports ongoing product stability testing.
3. Develops and implements departmental operational procedures to ensure regulatory compliance (FDA, GMP, ISO, CLIA, OSHA, etc.). Ensures department adherence to established procedures.
4. Ensures timeliness and efficiency of product and material testing to meet production demands and promotes continuous improvement of departmental performance.
5. Initiates and completes OOS, NCMR, and CAPA investigations as required. Supports and participates in internal and external audits.
6. Ensures that all lab instruments are appropriately validated, calibrated and monitored for compliance. Reviews records for compliance per procedures and regulations.
7. Communicates the quality status of materials and processes to internal customers.
8. Develops and maintains regular Quality Control metrics. Trend and report metric data to communicate the effectiveness of current processes, test methods, and personnel performance.
9. Develops and maintains annual departmental budget plans.
10. Maintains environmental monitoring program compliance.
11. Works with other departments to ensure operational and quality goals are understood and met.
12. Supports review of customer complaints. Participate as needed on special teams and/or projects.
13. Leads team members by clearly establishing performance expectations, providing adequate training and resources, giving regular coaching, feedback and guidance. Ensures an engaged and skilled workforce through active listening and communication.
Knowledge, Experience, and Skills
1. Requires a Bachelors Degree in microbiology, chemistry or other scientific field.
2. Requires a minimum ten (10) years progressively responsible quality experience in an FDA regulated GMP environment (such as medical device).
3. Requires a minimum of eight (8) years progressively responsible experience in GLP lab work, performing varied testing and troubleshooting activities in high volume environment.
4. A minimum of five (5) years experience direct supervisory experience. Must demonstrate the ability to lead others by building relationships, provide coaching and feedback to employees, and delegate assignments as needed to ensure efficient work production.
5. Proven excellent verbal and written communication skills are a must as this position interacts at all levels of the organization.
6. Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
7. Must have a advanced knowledge of antibiotic / microorganism interactions and GMP compliance.
8. Must be able to demonstrate flexibility in responding to unexpected demands.