ESSENTIAL JOB RESPONSIBILITIES:
- Manages the Consumables IPT department daily work activities including: Team schedule, ensuring training, general guidance to direct reports and across functional groups, and serves as resource for technical / administrative problems.
- Hires, trains, motivates, leads, develops, and evaluates staff. Takes corrective action as necessary on a timely basis and in accordance with company policy.
- Ensures Quality Control systems are compliant with corporate and site procedures, as well as industry standards.
- Supports development of analytical methods. Works in conjunction with other departments to develop, qualify, and transfer testing analytical methods as applicable.
- Ensures maintenance of testing equipment - qualification, calibration and maintenance.
- Drafts, reviews, and approves Standard Operating Procedures (SOP), sampling plans, specifications, protocols and reports related to product/processes, equipment, method, validation. This includes deviation investigation and reporting.
- Develops and implements statistical tools for monitoring and review.
- Identifies and implements improvement opportunities for established processes, procedures, and training to support CAPA, Change Control, Deviation, Risk Management, and Investigation processes.
- Lead investigations for failures during testing; perform troubleshooting, process development or improvement activities.
- Complete all assigned and required training satisfactorily and on time
Education and Experience:
- High school degree with 8+ years of experience or Bachelor's degree with 5+ years of experience OR Master's degree with 3+ years of experience.
Knowledge and skills:
- Experience with managing people and providing leadership.
- Thorough knowledge of cGMP regulations related to Quality Control required.
- Experience with analytical method, and Microbiology testing.
- Proven track record in method validation / qualification and qualification of equipment / systems.
- Experience with facility / laboratory expansions.
- Experience in a QC support in high pace manufacturing setting.
- Experience working in a GMP/ISO/FDA manufacturing environment
- Experience using analytical scales, Pipettes and working with hazardous chemicals
- Flexibility with the work schedule including modified shift times and weekends