Quality Control Manager
The Quality Control Manager will manage the QC labs in support of all QC testing activities from Receiving/Incoming testing of raw materials to in-process testing to finished goods testing. They will be responsible for ensuring overall compliance of the QC labs, ensure SOP’s are accurate and up to date, QC test equipment is calibrated and all QC personnel are fully trained. In addition, the QC Manager will be responsible for ensuring all testing in prioritized based on the business needs and both shifts are adequately staffed. Additional responsibilities include process improvements, assess lean operations of the lab process, conducting/participating in kaizens, coordinating testing with outside labs, evaluating potential new vendors and addressing issues with outside lab testing, interact with department heads to ensure optimal flow of material in QC labs, support internal/external audits, ensure compliance to GMP and other regulatory requirements, department training and SOP maintenance, Quality data trending, setting department goals, assessing and tracking non-conformances, CAPA’s and attending/participating in both MRB’s and Daily Management.
Essential Job Functions
- Schedule QC tests and ensure completeness, timeliness and overall compliance.
- Coordinates activities of Raw Material, Finished Product and Microbiology staff in testing incoming raw materials and components, and finished product. Coordinates with Manufacturing and Packaging for production schedule, material and finished product testing. Coordinates with Quality Assurance department regarding release of raw materials/ components and finished product for release and distribution.
- Coordinates with Manufacturing and Packaging for production schedule, material and finished product testing.
- Coordinates with Quality Assurance department regarding release of raw materials/ components and finished product for release and distribution.
- Ensure cGMP compliance in all aspects of laboratory operations
- Observes and follows company guidelines, SOPs, policies, procedures and FDA regulations.
- Develop, improve and implement SOPs for various quality control operational procedures including training, trending, equipment maintenance and calibration, method execution, investigations, and laboratory processes. Creates and revises raw material, component and finished product specification forms and worksheets.
- Investigate out-of-specification results and write investigation reports.
- Perform data review, trending analyses and prepare protocols and report to support all areas of laboratory operations.
- Recruit and develop a high performing team with diverse backgrounds and talents. Conducts regular training for the quality control group.
- Coach and counsel team members to develop their skill sets and create an environment of continuous learning, improvement and innovation.
- Maintain and communicate performance metrics for the team, setting and maintaining high expectations for team performance.
- Develop and drive staff schedules to meet workflow demands and monitors expenditures to prevent budget overruns.
- Provide technical guidance to QC and serves as subject matter expert in cross functional, cross departmental work teams.
- Performs other duties inherent of the position, and additional duties that may be assigned by supervisor.
- B/S or higher Science or Technical Degree
- Quality Certifications a plus (CQE, CQA etc.)
- Lean/Six Sigma certifications a plus (green belt or black belt)
- 3-5+ years experience working in an FDA regulated industry.
- Computer Proficient with Microsoft Office, Excel and other software’s necessary to work as a Compliance Officer
Job Type: Full-time
Salary: $75,000.00 to $85,000.00 /year
- FDA: 5 years (Preferred)
- Quality Certs CQE, CQA etc.: 4 years (Preferred)
- Excel: 5 years (Preferred)
- Quality Control: 5 years (Preferred)
- Lean Six Sigma: 4 years (Preferred)