QC Manager
at Thermo Fisher Scientific
Middletown, VA 22645, USA -
| Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
|---|---|---|---|---|---|---|---|
| Immediate | 25 Nov, 2024 | Not Specified | 29 Aug, 2024 | 7 year(s) or above | Risk Assessment,Critical Thinking,Documentation Practices,Microbiology,Regulated Industry,Molecular Biology,Equipment Maintenance,Test Procedures,Staff Scheduling,Biochemistry,Pharmaceutical Sciences,Validation,Instrumentation,Testing,Method Transfer | No | No |
Required Visa Status:
| Citizen | GC |
| US Citizen | Student Visa |
| H1B | CPT |
| OPT | H4 Spouse of H1B |
| GC Green Card |
Employment Type:
| Full Time | Part Time |
| Permanent | Independent - 1099 |
| Contract – W2 | C2H Independent |
| C2H W2 | Contract – Corp 2 Corp |
| Contract to Hire – Corp 2 Corp |
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
