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QC Scientist II

Company: Thermo Fisher Scientific
Location: Frederick
Posted on: July 22, 2021

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.

How will you make an impact?

This individual will be responsible for the quality control testing of Next Generation Sequencing products. This is a Monday-Friday 8am-5pmEST position.

What will you do?

  • Plans and performs quality control testing of reagents and kits utilizing the Next Generation Sequencing technology (ION Torrent platform).
  • Conducts quality control tests using HPLC, HPIC, UV/Vis, qPCR and mass spec methods.
  • Collects and analyzes data for final disposition using preapproved documentation as well as troubleshoots assays in Excel.
  • Assist QC Manager with managing QC schedules
  • Participate in QC Method Validation and Method Transfer activities
  • Support New Product Initiatives.
  • Participate in stability study activities
  • Train new and existing QC operators 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 SPC’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.

How will you get here?

  • Bachelor's degree in Biology, Molecular Biology, Biochemistry, Chemistry, Life Sciences, or other related discipline required.
  • 3+ years of QC experience
  • Experience working within a Medical Device environment.
  • Knowledge of NGS (Next Generation Sequencing) i required.
  • Experience working in a cGMP lab compliance environment
  • Experience in working in FDA regulated environment.
  • Experience with ISO 13485 and cGMP
  • Experience with pipetting techniques
  • Proficiency in Excel
  • 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.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

Keywords: Thermo Fisher Scientific, Frederick , QC Scientist II, Other , Frederick, Maryland

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