Quality Control Analyst – QC Testing Group in Cambridge, MA at Integrated Resources, Inc

Date Posted: 8/8/2020

Job Snapshot

Job Description

  • Perform cGMP analytical testing (pH, osmolality, appearance, bioassay, cell culture, flow cytometry, qPCR, and ELISA)
  • Review and evaluate raw data (peer review level)
  • Author SOPs/Forms and technical reports with guidance
  • Initiate laboratory deviations and support investigations (IA, OOS, AR), performing assessment, authoring protocols/reports and investigation closure with guidance
  • Author, review, and execute equipment validations with guidance
  • Support operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data integrity/control, cGMP documentation, LIMS, laboratory audit, and method training)
  • Execute phase-appropriate test method validation protocols as needed
  • Participate in providing the necessary information for regulatory filings and inspections.
  • Support CAPA/Continuous Improvement Initiatives
About You:
  • BS with 4+ years in a biotechnology discipline
  • 4+ years of experience in a cGMP/GxP environment is preferred
  • Preferable hands on experience in cell culture, flow cytometry, quantitative PCR, and other bioanalytical methods such as ELISA
  • Superb organizational, analytical, and communications skills and "do-what-it-takes attitude
  • A passion for addressing the critical unmet medical needs of patients