Job Title: Staff QC Engineer Scientist
Requisition ID: 57444BR
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.
- This role will be responsible for all ION Torrent new product method transfers from R&D to the Quality Control Laboratory in Frederick.
- Serve as Quality Control Subject Matter Expert for ION Torrent and Next Generation Sequencing products.
- Represent Frederick QC on New Product Introduction team for the ION Torrent line of products.
- Plans and performs quality control testing of reagents and kits utilizing the ION Torrent platform, PGM Dx, One Touch, HPLC, qPCR and mass spec.
- Collects and analyzes data for final disposition using preapproved documentation as well as troubleshoots assays.
- Assist QC Manager with managing QC schedules
- Develop and manage a compliant QC Stability testing program for ION Torrent and Reagent QC.
- Participate in QC Method Validation and Method Transfer activities
- Train new and existing QC scientist on new and existing Quality Control test methods.
- Establishes and manages QC metric, data trending, and drives actions for improvement.
- Performs and documents equipment maintenance.
- Update QC test methods, QBR’s, forms, and SP’s to align with current laboratory practices and improvements
- Maintain laboratory testing inventory and supplies
- Write and execute stability protocols and reports.
- Preparing samples
- Instrument start up
- Perform and document equipment maintenance
- Perform peer review of QC data packets
- Initiates problem reporting (deviations, non-conformances, failures, corrective and preventive actions) via TrackWise and performs root cause investigation and analysis for OOS and complaints.
- Ensuring the laboratory is well-stocked and resourced
- Recording and sometimes interpreting results to present to senior colleagues
- Using computers and performing mathematical calculations for the preparation of graphs
- Keeping up to date with technical developments, especially those which can save time and improve reliability
- Following and ensuring strict safety procedures and safety checks
- Perform other activities as directed by QC Supervisors and Senior Manager QA/QC
- Bachelor’s Degree in Science
- 6+ Years of clinical laboratory and cGMP Quality Control Laboratory experience.
- Working knowledge of general cGMP lab compliance.
- Good pipetting technique
- Proficiency in Excel and Jump or Minitab
- Ability to perform independently & as part of a team.
- Ability to work in dynamic, fast paced team environment.
- Excellent communication/interpersonal and presentation skills.
- Experience writing & reviewing technical documentation.
- Experience in working in FDA regulated environment
- Experience with the following instrumentation (Ion Torrent, Next Generation Sequencing, qPCR, HPLC, HPIC, Quantstudio, Liquid Gas Chromatography, Mass Spectroscopy, Gel Imager, etc.
- Experience in Pharmaceutical, Medical Device, or clinical lab QC environment
- Experience with ISO 13485 and cGMP
- Experience working in a FDA Regulated environment
This position does not have relocation allowance
At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com
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.
Join our Talent Community
If you're ready to make a difference in the world, you can do it here.Join