Job ID :
US - Maryland - Frederick
Key Objectives of the role:
- 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.
- Establishes and manages QC metric, data trending, and drives actions for improvement.
- Initiates problem reporting (deviations, non-conformances, failures, corrective and preventive actions) via Trackwise and performs root cause investigation and analysis for OOS and complaints.
- Performs and documents equipment maintenance.
- Preparing samples
- Instrument start up
- Perform and document equipment maintenance
- 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
Minimum Qualifications (must have):
- Bachelor's degree in Molecular Biology, Biochemistry, Chemistry or other related discipline
- Working knowledge with Next-Gen sequencing or Master's degree in related discipline.
- Good pipetting technique
- Proficiency in Excel and Jump or Minitab
- 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.
- Experience in working in FDA regulated environment.
Preferred Qualifications (nice to have):
- Experience with the ION Torrent platform
- Experience in Pharma, Medical Device, or clinical lab QC environment
- Experience with ISO 13485 and cGMP
- Experience working in a FDA Regulated environment