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Reference # : 19-01735 Title : QC Associate
Location : Devens, MA
Position Type : Contract
Experience Level : Start Date / End Date : 10/21/2019 / 04/20/2020  
Description
QC ASSOCIATE
DEVENS, MA

Project Description:
This position will be responsible for performing activities within the Quality Control Sample Management Department including receipt, logistics, inventory, and disposal of various sample types in support of Quality Control testing in a GMP Quality Control Laboratory in accordance with local and global SOPs, regulatory guidelines, and EHS procedures.
  • Receive and aliquot Drug Product and Drug Substance release and stability samples.
  • Perform inventory for sample types including test reserves, critical reagents, and regulatory retains.
  • Prepare and ship samples to third parties for testing.
  • Transcribe data into Sample Manager LIMS system in support of Drug Substance lot disposition.
  • Prepare and ship stability samples to third party stability sites.
  • Schedule and coordinate maintenance for controlled temperature units (CTUs), Pipettes, and Biosafety Cabinets (BSC).
  • Dispose of samples when authorized.

Required Skills:
  • Experience with good documentation practices (GDP).
  • Experience working in a BSC.
  • Experience in at least one of the computerized systems (Maximo, SMLIMS, Velquest LES, DCA, DeltaV, Trackwise).
  • Experience working in a GxP QC laboratory environment (2+ years).
  • Experience working with dry ice, biological waste, and sharps.
  • Experience with and understanding of Data Integrity as it pertains to a GMP/GLP environment.
  • Experience with SMLIMS, LES, and/or Maximo.
  • Experience in shipping temperature controlled materials to contract test labs (CTLs).
  • Regulatory or QA audit exposure in a GMP / GLP environment.
  • Experience with or understanding of biologic / cell culture manufacturing process.
  • Multitasking and attention to detail.
  • Bachelor's Degree in related field.
  • Strong verbal and written communication skills.
  • Ability to work independently and as part of a team.
  • Position Handles Hazardous Materials.



This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Alex: alex@alphaconsulting.com

ALPHA'S REQUIREMENT #19-01735
W2 ONLY MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

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