QC Scientist II
Company: Thermo Fisher Scientific
Posted on: July 22, 2021
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
- 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
- Assist QC Manager with managing QC schedules
- Participate in QC Method Validation and Method Transfer
- 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
- Ensuring the laboratory is well-stocked and resourced
- Recording and sometimes interpreting results to present to
- 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
- 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
- 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
- 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
Keywords: Thermo Fisher Scientific, Frederick , QC Scientist II, Other , Frederick, Maryland
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