People Matter

Senior QC Specialist, Sample Management

Editas Medicine

Editas Medicine

Cambridge, MA, USA
Posted on Friday, June 7, 2024

At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing.

We believe our people are at the core of everything we do, and we’re committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.

Together, we are leading the way towards a healthier and more equitable future.

Position Summary

Editas Medicine is seeking a Senior Specialist, QC Sample Management, who can support the activities related to sample management/sample submission for internal testing and testing performed at contract organizations. This person will also coordinate testing related activities and support efforts to obtain and review results. The ideal candidate will have experience with a variety of analytical testing methods including, but not limited to HPLC, UV, CE, Bioassay, PCR, Gel Electrophoresis and compendial testing. Candidates must have hands-on experience and demonstrated organizational skills in a regulated analytical/QC environment.

Key Responsibilities

  • Coordination of sample shipments for product release and results tracking
  • Reviews QC testing data and/or Biologics analytical methods generated by vendor test labs.
  • Supports vendor OOS/ATI/Investigations, verifies that data meets current specifications, generates COA(s), and tracks cycle time metrics, captures related deviations, OOS, CAPAs, atypical results, change controls.
  • Assists in the planning of basic unit operations
  • May communicate with vendor test laboratories.
  • Works with department peers to execute well defined assignments.
  • Prepares protocols/reports as appropriate/necessary
  • Reviews and interprets data with support from a supervisor
  • Identifies and communicates routine technical problems and data and vendor issues within the scope of responsibility
  • Assists with method transfer and method validations at vendors as appropriate.
  • Initiate workflows for protocol and report uploads/approvals in relevant electronic documentation systems
  • Downloads data from vendor sharepoints/databases/LIMS.