Work Schedule
First Shift (Days)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

Job Description

As the Quality Control Supervisor, you will be responsible for leading the daily operations of the Quality Control lab. This includes managing a team, implementing testing procedures, and collaborating with other departments. You must have strong organizational, communication, and analytical skills, as well as a background in microbiology and lab experience.

• Lead 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.
• Manage QC team, including interviewing, hiring, performance management.
• Support QC manager by monitoring 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 countermeasures.
• Collaborate with cross-functional teams 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.
• Foster a safety culture by conducting routine Gemba walks and facilitating employee engagement in safety. Report any safety hazards to the Manager, HR, Safety Specialist, or Senior Management, and address and accurate safety issues. Ensure the lab follows all safety procedures.
• Apply continuous improvement and lean tools to optimize lab operations.
• Build visual management tools to track 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.

• Bachelor's degree in biological sciences, with a preference for microbiology required.
• Minimum of 5 years of microbiology lab experience.
• Ability to balance 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.

• 2-5 years in a lab/supervisory role.
• Understanding of FDA regulations for medical devices and familiarity with USP and CLSI requirements.