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Apex Life Sciences

QC Scientist

Post Date:Dec 29, 2017Type:Contractor
Start Date:12/29/2017Salary:
Location:US-MD-Frederick Job Reference:803812
Skills:
 

Job Description:

We are searching for a tenured Quality Control Scientist to join our growing team in Frederick, MD for a long-term contract!

Responsibilities

  • Plan/perform quality QC testing of reagents and kits using HPLC, qPCR and mass spec
  • Collect/analyzes data for final disposition using preapproved documentation
  • Lead reagent QC Method Validation and Method Transfer
  • QC method validation reports for reagents
  • Train new and existing QC scientist on QC test methods
  • Establishes and manages QC metric, data trending, and drives actions for improvement.
  • Update QC test methods, QBR’s, forms, and SP’s to align with current laboratory practices and improvements
  • Deviations, non-conformances, failures, corrective and preventive actions via TrackWise
  • Perform root cause investigation and analysis for OOS

Minimum Qualifications:

  • 6+ Years of clinical laboratory and cGMP Quality Control Laboratory experience
  • 4 year degree in Chemistry, Biology or other science related field
  • Knowledge of general cGMP lab compliance.
  • Good pipetting technique
  • Proficiency in Excel and Jump or Minitab
  • Experience writing & reviewing technical documentation
  • Experience in working in FDA regulated environment

Preferred Qualifications (nice to have):

  • Ion Torrent, qPCR, HPLC, HPIC, Quant studio, Liquid Gas Chromatography, Mass Spectroscopy, Gel Imager
  • Experience in Pharmaceutical, Medical Device, or clinical lab QC environment
  • Experience with ISO 13485 and cGMP




Contact Information
Apex Life Sciences



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