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Job ID :
66509BR
Location :
US - Maryland - Frederick
:
Job Description

Job Title: Scientist II - QA/QC
Requisition ID: 66509BR

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.

Responsibilities:

  • Plans and performs quality control testing of reagents and kits utilizing the ION Torrent platform, HPLC, qPCR and mass spec.
  • Collects and analyzes data for final disposition using preapproved documentation as well as troubleshoots assays.
  • Serve as Quality Control Subject Matter Expert across all three functional QC groups.
  • Assist QC Supervisors with managing QC schedules
  • 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
  • Leads continuous improvement projects.
  • Performs other related duties as required and/or assigned.

Minimum Qualifications:
  • Bachelor's degree in Biology, Molecular Biology, Biochemistry, Chemistry, Life Sciences, or other related discipline.
  • 3 - 5 years of related experience working in a biological quality control laboratory environment.
  • Experienced within a biological quality control laboratory environment.
  • Experience in cell culture and aseptic technique.
  • Perform independently Biological Assays.
  • Experience in Proliferation and Cytotoxicity testing.
  • Experience in Inhibition of Proliferation, Chemotaxis, and ALP.
  • Experience with isolation of PBMCs and Spleenocytes.
  • Highly organized with strong attention to details.
  • Ability to perform independently & as part of a team.
  • Ability to lead moderately complex projects.
  • Ability to work in a dynamic fast paced team environment.
  • Excellent communication/interpersonal and presentation skills.
  • Experience writing & reviewing technical documentation.
  • Collects and analyzes data for final disposition using preapproved documentation as well as troubleshoots assays.
  • Experienced with EHS guidelines in a laboratory environment, maintain well documented laboratory protocols and notebooks.
  • Performs and documents equipment maintenance.

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
  • Possesses a strong scientific and technical background, sufficient to establish credibility with team as well as the manufacturing.
  • Experience performing DNAse/RNAse assays using various instruments.
  • Initiates problem reporting (deviations, non-conformances, failures, corrective and preventive actions) via Trackwise and performs root cause investigation and analysis for OOS and complaints.


This position is not approved for relocation assistance


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.




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.
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