QC Manager
at Thermo Fisher Scientific
Middletown, VA 22645, USA -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 26 Dec, 2024 | Not Specified | 28 Sep, 2024 | 7 year(s) or above | Pharmaceutical Sciences,Method Transfer,Biochemistry,Validation,Testing,Molecular Biology,Regulated Industry,Equipment Maintenance,Test Procedures,Risk Assessment,Documentation Practices,Instrumentation,Staff Scheduling,Microbiology,Critical Thinking | No | No |
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Description:
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.
EDUCATION/QUALIFICATIONS:
- 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
Responsibilities:
Please refer the Job description for details
REQUIREMENT SUMMARY
Min:7.0Max:12.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
Graduate
Biochemistry microbiology molecular biology pharmaceutical sciences or related field
Proficient
1
Middletown, VA 22645, USA