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Senior QC Specialist
Confirmed live in the last 24 hours
Cambridge, MA, USA
Experience Level
  • Proven ability to work independently as well as to collaborate and communicate effectively and work effectively in a team-oriented environment
  • A strong understanding of applicable regulations and guidelines pertaining to pharmaceutical product development. manufacturing, testing and clinical operations
  • Previous experience in Quality Control and specifically Stability is required
  • Experience in a broad variety of analytial testing techniques, including HPLC, UV, CE, Bioassay, PCR, Gel Electropherisis, GC-MS, cell-based potency, and biological assays
  • Experience in statistical analysis of analytical data, including biological assays
  • Proficiency in the use of Excel, PowerPoint, Veeva eDMS, and JMP statistcal software
  • Good verbal and written communication skills
  • Demonstrated ability to collaborate with both internal and external parties to achieve targeted objectives
  • Demonstrated organizational skills to managing multiple projects and priorities
  • BS Degree in Biology, Chemistry or other Life Sciences
  • Minimum of 5 years of related experience
  • Experience in Quality setting with particular interest in stability studies and data trending
  • Minimal travel will be required
  • Onsite work at multiple facilities in Massachusetts (Cambridge and Waltham) will be necessary
  • Manages stability sample submissions to internal and external testing labs
  • Manages tracking of the stability sample pull schedule per approved protocols
  • Performs data review, interprets results, compares results to approved specifications, generates Certificate of Analyses (COAs) and enters data into database
  • Trends stability data for critical components, drug substance and drug product using statistical software. Experience with JMP is preferred
  • Routinely communicates stability trends and changes to expiration dating to CMC Teams
  • Prepares protocols and reports and initiates document workflows in eDMS. Experience with Veeva preferred
  • Prepares stability sections for IND, IMPD, BLA and MAA as requested
  • Collaborates with peers to execute well defined assignments
  • Identifies and communicates technical problems anddata discrepancies
  • Supports OOS, OOT, and Investigations and works with QA on associated deviations, CAPAs, and change controls. Assists with method transfer and method validations at vendors as appropriate
Editas Medicine

51-200 employees