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Quality

Senior QC Analyst

  • Cambridge, MA
  • Added
31

Position Overview:

The QC Senior Analyst will support critical analytical method implementation workstreams in support of the laboratory start-up plan. These workstreams include analytical instrument qualification, critical reagent management, execution of technical protocols, and supporting the implementation of programs and procedures in a new Quality Control laboratory located in Cambridge, Massachusetts.

Primary Responsibilities:

  • Contribute to setup of the QC laboratory including instrument purchasing, IQ/OQ/PQ, and operation SOPs.
  • Collaborate with multiple departments to setup BMS, CMMS, validation software, LIMS and system SOPs for the QC laboratory.
  • Maintain and operate analytical instrumentation for a variety of analytical methods.
  • Analyze data; interpretation of data within given parameters.
  • Investigate out of specification or unexpected results and study outcomes.
  • Escalate and assist in the resolution of complex issues.
  • Independently develop, author, and execute protocols, reports and other related documents.
  • Communicate effectively with peers, and demonstrate collaboration across different functions.
  • Support the implementation and execution of training programs and processes for less experienced QC Analysts.
  • Draft and review technical documents.
  • Maintain stability sample inventory and perform stability sample shipments to external contract laboratories and/or sample storage vendors.
  • Support stability data analysis along with stability document reviews.
  • Managing and ordering of laboratory reagents and materials.
  • General cleaning and upkeep of the laboratory.

Qualifications:

  • Bachelor’s degree required, preferably in a life science discipline.
  • 5+ years relevant experience.
  • Advanced hands-on experience with various analytical techniques including bioassays, flow cytometry, sequencing, PCR, Mass spec.
  • Scientific knowledge and direct experience with analytical method transfer requirements and processes.
  • Advanced technical writing skills.
  • Advanced problem-solving ability.
  • Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
  • Advanced ability to communicate effectively with peers, department management and cross-functional peers.

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