myGwork - LGBTQ+ Business Community · 12 hours ago

Supervisor, QC

United States

Full-time

Remote

Senior Level

5+ years exp

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Responsibilities

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.

Qualification

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MicrobiologyQuality ControlFDA regulationsSAPSupervisory experienceMicrosoft OfficeContinuous improvement