Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Able to lift 40 lbs. without assistance

Job Description

At Thermo Fisher Scientific, we have an exceptional opportunity for a QC Manager to join our world-class manufacturing organization in Middletown, VA. As a QC Manager, you will play a crucial role in ensuring the flawless quality and reliability of our in vitro diagnostic (IVD) products. With over 35 years of experience, we are a trusted supplier in the IVD industry, and your contributions will directly impact the lives of patients worldwide.

Position Requirements:

• Direct oversight and management of the QC department, including incoming, in-process, and release testing.
• Provide supervision and direction to employees, empowering them to perform at their best.
• Ensure the QC lab is functioning efficiently, maintaining proper inventory levels, equipment maintenance, and staff scheduling.
• Use critical thinking to analyze situations and data to make informed decisions and take appropriate actions.
• Establish and lead QC metrics and data trending to drive continuous departmental improvements.
• Ensure proper training of staff in testing, instrumentation, and methodologies.
• Lead the development, updating, and review of Test Procedures, SOPs, and Protocols.
• Guide the team on risk assessment, method transfer, and validation of test methods.
• Troubleshoot and investigate instrument and product-related issues.
• Implement regulatory and in-house requirements to uphold the highest quality standards.

• Degree (BS) in Biochemistry, Microbiology, Molecular Biology, Pharmaceutical Sciences, or related field.
• 7+ years Biotech experience within regulated industry
• 5+ Years of experience managing QC team
• Experience in a cGMP environment is required
• Knowledge and use of Good Documentation practices is required
• Ability to learn quickly and make sound, scientifically driven decisions that adhere to regulatory practices is required
• Experience with internal, external, and customer audits

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