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Quality Control Contract Scientist III Quality Control Contract Scientist III
Ref No.: 17-15494
Location: Frederick, Maryland
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
Responsibilities:
Plans and performs quality control testing of reagents and kits utilizing general laboratory equipment such as HPLC, qPCR and mass spec.
Collects and analyzes data for final disposition using preapproved documentation as well as troubleshoots assays.
Lead all reagent QC Method Validation and Method Transfer activities
Write method validation protocols and reports for reagent QC.
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

6+ Years of clinical laboratory and cGMP Quality Control Laboratory experience.
4 year degree in Chemistry, Biology or other science related field.
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.
Preferred Qualifications (nice to have):
Experience with the following instrumentation (Ion Torrent, qPCR, HPLC, HPIC, Quant studio, Liquid Gas Chromatography, Mass Spectroscopy, Gel Imager, etc...)
Experience in Pharmaceutical, Medical Device, or clinical lab QC environment
Experience with ISO 13485 and cGMP