Engineer/Scientist I – QC

Local Jobs Thermo Fisher Scientific in Software Development
  • United States, Frederick, MD 21701 View on Map
  • Post Date : September 16, 2020
  • Apply Before : October 16, 2020
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Job Description

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:

  • Plan and perform quality control testing of reagents and kits utilizing the ION Torrent platform, Bioanalyzer, HPLC, HPIC, UV/Vis, qPCR and mass spec
  • Collects and analyzes data for final disposition using preapproved documentation as well as troubleshoots assays
  • Participate in QC Method Validation and Method Transfer activities
  • Support NPI projects
  • Participate in stability study activities
  • Train new and existing QC operators on new and existing Quality Control test methods.
  • Establishes and manages QC metrics, data trending, and drives actions for improvement.
  • Performs and documents equipment maintenance.
  • Update QC test methods, QBR’s, forms, and SPC’s to align with current laboratory practices and improvements
  • Maintain laboratory testing inventory and supplies
  • Write and execute stability protocols and reports
  • Prepare samples
  • 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 Manager

Minimum Qualifications/Requirements:

  • Degree in Biochemistry, Chemistry, Molecular Biology, or related degree
  • MS + 1-2 years relevant industry experience
  • BS + 3-5 years relevant industry experience
  • Hands on experience with NGS technologies or a very strong understanding of Ion Torrent sequencing technology
  • Must be skilled in basic molecular biology techniques: qPCR, DNA and RNA isolation and characterization
  • Working knowledge of general cGMP lab compliance
  • Good pipetting technique
  • Proficiency in Excel
  • Ability to perform independently and 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:

  • Experience with Ion Torrent instruments and sequencing applications
  • Experience with the following instrumentation (HPLC, HPIC, Liquid Chromatography, Mass Spectroscopy, Gel Imager, etc.)
  • Experience in Pharmaceutical, Medical Device, or clinical lab QC environment
  • Experience with ISO 13485 and cGMP

This position is not approved for relocation benefits.

At Thermo Fisher Scientific, each one of our 75,000 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.

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