Quality Control Supervisor
About The Position
The Quality Control Supervisor is responsible for leading all aspects of the daily operations of the Quality Control laboratory, ensuring that all processes and products meet established standards and regulatory requirements. This role involves managing a team of Quality Control employees, developing and implementing testing procedures, and collaborating with other departments to investigate product failures and optimize lab operations. The supervisor will ensure compliance with FDA regulations, Good Manufacturing Practices, and other relevant guidelines. Key responsibilities include staff development, budget management, root cause analysis, and leading continuous improvement initiatives. The supervisor must possess strong interpersonal, communication, and analytical skills, along with a proven background in microbiology and laboratory experience.
Requirements
- Bachelor's degree in biological sciences, with a preference for microbiology.
- Minimum of 5 years of microbiology lab experience
- Ability to lead multiple tasks in an organized fashion.
- Strong interpersonal skills for effective interaction with various departments regarding quality testing parameters.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint) and experience with SAP preferred.
- Strong problem-solving and analytical abilities.
- Highly responsible, self-motivated, and team focused.
- Excellent verbal and written skills in English.
Nice To Haves
- 2-5 years in a lab/supervisory roll with direct reports
- Understanding of FDA regulations for medical devices and familiarity with USP and CLSI requirements.
Responsibilities
- Direct the daily activities of the Quality Control laboratory, assigning job duties to employees as needed.
- Assist Manufacturing, Manufacturing Sciences, QA, and QS teams in investigating product failures.
- Train and develop technical staff, demonstrating appropriate skills and requirements for general product testing.
- Ensure all duties are performed in accordance with Standard Operating Procedures, FDA regulations, and Good Manufacturing Practices.
- Lead QC team, including interviewing, hiring, performance management
- Support QC manager by supervising expenses against departmental budget.
- Develop, document, and implement Quality Control procedures.
- Investigate out-of-limit test results, handle deviations, analyze and write risk assessments and initiate root cause counter measures.
- Collaborate with cross functional team to develop testing plans for new devices and update existing tests to align with CLSI or USP guidelines.
- Ensure timely review of all finished goods.
- Cultivate a safety culture by conducting routine Gemba walks and facilitate employee engagement in safety.
- Report any safety hazards to the Manager, HR, Safety Specialist, or Senior Management, and address and correct safety issues.
- Ensure the lab follows all safety procedures.
- Apply continuous improvement and lean tools to optimize lab operations.
- Build visual management to tools to supervise critical data and improve lab performance.
- Communicate the status of critical back-order items through daily management.
- Lead and drive 5S and standard work initiatives, ensuring the laboratory operates in a clean and organized manner.
- Lead key projects, including the integration of new products, equipment and processes into the laboratory.
- Other duties may be assigned as business needs warrant.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
5,001-10,000 employees
