Quality Control Manager
2 days ago
Thermo Fisher Scientific is seeking a highly skilled QC Manager to join our world-class manufacturing organization in Middletown, VA. As a key member of our team, you will play a crucial role in ensuring the quality and reliability of our in vitro diagnostic (IVD) products.
Key Responsibilities:- 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
- Competitive remuneration
- Annual incentive plan bonus
- Healthcare
- Range of employee benefits
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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