- 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
- 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
- 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.
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