Quality Control Manager

Cambridge, Massachusetts
Industry: Industrial
Job Number: JN -112020-57288

Title: Quality Control Manager

Location: Cambridge, MA

Job Type: Long Term Contract


Responsibilities:

  • Oversee all aspects of stability study execution
  • Contribute to the development of relevant SOPs, protocols, reports and stability sections for regulatory submission
  • Work closely with Manufacturing, Quality Control and Quality Assurance to schedule and coordinate activities required to execute product stability studies
  • Work closely with Regulatory and Clinical Operations to coordinate activities required to support product throughout clinical studies
  • Serve as a technical lead for, and contribute to writing of, Quality Incidents, Deviations, Investigations, CAPAs and Change Controls
  • Perform data review and statistical analyses to establish, extend and/or support expiration dates
  • Work closely with vendors to expense and manage outsourced testing


Required Skills:

  • At least 5 years’ experience in biopharmaceutical product stability with experience overseeing a stability program.
  • 10+ years of recent professional experience in a QC lab with 2-4 years supervisory experience
  • Experience drafting stability protocols, writing stability sections for regulatory filings with a strong understanding for the guidelines
  • Expertise in stability guidance documents, GMP documentation and pharmaceutical quality systems
  • Proficiency with Microsoft Word, Excel, JMP and PowerPoint
  • 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.
  • Experience with biological and/or chemical assays preferred
  • Experience with analytical equipment troubleshooting preferred
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