Manager QC
Manager QC
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
Able to lift 40 lbs. without assistance Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cold Room/Freezers 22degreesF/6degrees C Laboratory Setting Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.Job Description
Join the Thermo Fisher Scientific team for impactful work innovative thinking and a customercentric culture.
Location/Division Specific Information
CDD offers diagnostic solutions for IVD market segments and has been a trusted supplier for 40 years.
Discover Impactful Work:
Middletown VA team supports top IVD suppliers as OEM/contract manufacturer trusted for 35 years.
A day in the Life:
- Lead and run a Quality Control team responsible for raw material management and product release testing.
- Redesign the vision for the QC team based on our evolving and growing business.
- Coach mentor and develop people and encourage a culture of learning.
- Establish QC metrics data trending and drive actions for department improvements.
- Partner with crossfunctional team members to drive and implement critical quality attributes crossfunctional and crosssite initiatives.
- Drive the implementation of analytical tools and techniques to ensure robust Quality products.
Position Requirements:
- Direct oversight and management of the QC department that includes incoming in process and release testing.
- Maintain accurate inventory levels of lab supplies equipment calibration and staff scheduling in the QC lab.
- Provide direct supervision and direction to employees according to established policies and management mentorship.
- Work on issues where analysis of the situation or data requires review of relevant factors and exercises judgement based on procedures/policies to determine appropriate action.
- Establish and manage QC metrics data trending and drive actions for department improvements.
- Ensure accurate training of all staff regarding testing instrumentation and methodologies.
- Contribute to Development Updating and/or review of Test Procedures SOPs and Protocols as assigned.
- Guide the team on approach to risk assessment of methods transferred from clients test method transfer verification/qualification and validation of test methods.
- Perform troubleshooting and investigations of instruments and productrelated OOS.
- Align with all regulatory/inhouse requirements (may include but is not limited to safety housekeeping laboratory chemical waste cGMP GDP documentation) when performing the assigned activity.
- Exhibit professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the companys policies and practices.
Education/Qualifications:
- Degree or equivalent experience 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.
Benefits
We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forwardthinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!
Apply today!
Accessibility/Disability Access
Thermo Fisher Scientific provides accessibility services for job seekers needing accommodations in the application process. This may involve help for hearing vision mobility or cognitive challenges.
Required Experience:
Manager
Employment Type
Full-Time
