Quality Control Lead Technician (2nd Shift)
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Job Location:
Middletown, DE - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Second Shift (Afternoons)Environmental Conditions
Able to lift 40 lbs. without assistance Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed Laboratory Setting No contact lens allowed; prescriptive glasses will be provided Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.) Standing for full shift Will work with hazardous/toxic materialsJob Description
At Thermo Fisher Scientific team youll discover impactful work innovative thinking and a culture dedicated to working the right way for the right reasons - with the customer always top of mind. The work we do matters like helping customers find cures for cancer protecting the environment and making sure our food is safe. As the world leader in serving science with the largest investment in R&D in the industry our colleagues are empowered to realize their full potential as part of a fast-growing global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.
Location/Division Information
Clinical Diagnostics Division in Middletown VA. This position is for the 2nd shift which typically starts between 12:00 PM and 3:00 PM.
Major Responsibilities:
- Lead Out-of-Specification (OOS) investigations from initiation through final report completion including cross-functional collaboration and root cause analysis.
- Perform NCR/CAPA root cause investigations with detailed analysis and documentation.
- Complete MOC/CO (Management of Change/Change Orders) processes.
- Serve as subject matter expert on specific areas and/or instruments providing technical mentorship to cross-functional teams.
- Prioritize and manage daily/weekly QC laboratory testing schedules for assigned area(s) with strategic operational oversight.
- Coordinate daily scheduling activities when Team Lead position is not present in assigned area.
- Supervise and uphold re-examination/reassessment procedures for raw materials to guarantee regulatory adherence and operational effectiveness.
- Implement detailed departmental data review for raw materials in-process samples release-to-fill samples component samples final kit samples stability samples and IAR samples.
- Run tier boards and facilitate technical discussions with cross-functional teams and management.
- Preserve instruments/equipment following manufacturers instructions and internal audit and calibration protocols.
- Ensure all laboratory activities align with cGMP GLP and ISO requirements.
- Keep accurate records/logs as per established procedures and regulatory requirements.
- Support business continuity through cross-training and coverage of critical laboratory functions.
Minimum Requirements/Qualifications:
- Bachelors degree in Chemistry Biology or related scientific field preferred or equivalent experience.
- 2 years of laboratory experience.
- This position is for the 2nd shift which requires availability during the afternoon and evening hours.
Benefits
We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!
Required Experience:
IC
Key Skills
- Quality Assurance
- Quality Inspection
- Calipers
- Coordinate Measuring Machine
- Food Industry
- GD&T
- ISO 9001
- Math
- Micrometer
- Quality Control
- HACCP
- Manufacturing
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
