Ref No.: 17-07560
Location: Frederick, Maryland
Position Type:Contract
Start Date: 11/10/2017
Job Category:Non-IT Scientific/ Clinical
Job Description:
Plans and performs quality control testing of reagents and kits utilizing general laboratory equipment such as HPLC, qPCR and mass spec.
Collects and analyzes data for final disposition using preapproved documentation as well as troubleshoots assays.
Lead all reagent QC Method Validation and Method Transfer activities.
Write method validation protocols and reports for reagent QC.
Train new and existing QC scientist 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 SP'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 by QC Supervisors and Senior Manager QA/QC.

Minimum Qualifications:
6+ Years of clinical laboratory and cGMP Quality Control Laboratory experience.
4 year degree in Chemistry, Biology or other science related field.
Working knowledge of general cGMP lab compliance.
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 following instrumentation (Ion Torrent, qPCR, HPLC, HPIC, Quant studio, Liquid Gas Chromatography, Mass Spectroscopy, Gel Imager, etc...
Experience in Pharmaceutical, Medical Device, or clinical lab QC environment.
Experience with ISO 13485 and cGMP.
Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
Contract Scientist III, Quality Control.