QC Associate

Cambridge, MA

Posted: 10/10/2019 Employment Type: Contract Industry: ERT Job Number: 230673

QC Associate
  • QC Associate needed for a 6 Month Contract role in Cambridge, MA.
  • Perform testing and review of in-process, release and stability for lipids and small molecule products under cGMP.
  • Mentor junior analysts on assay performance.
  • Identify and assist in Troubleshooting aberrant data, maintain validated equipment and perform multiple HPLC based and wet chemistry analytical methods.
  • Assist with guidance on investigations for Quality Instances, CAPAs, and Change Controls.
  • Participate in OOS/OOT investigations and work cross-functionally with quality assurance, process development, manufacturing, and research and development.

Required Skills:
  • BA/BS degree in Biochemistry (or a related field).
  • 2-5 years of recent professional experience in a QC lab.
  • Established background in performing HPLC based assays for proteins, lipids, and/or small molecules under cGMP.
  • Demonstrated experience in GMP quality systems.
  • Knowledgeable in most or all the following techniques: Particle Size, Peptide Map, Reverse Phase, SEC, CEX, SDS-PAGE, Bioanalyzer, pH, Osmolality and other standard wet chemistry methods.

Duration: 6 Month Contract


PLEASE NOTE: 3RD PARTIES/SUBCONTRACTORS/SUBCONTRACT AGENCIES ARE NOT ELIGIBLE FOR THIS POSITION.   SUBCONTRACT AGENCIES NEED NOT APPLY.
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