Senior Quality Control Associate

Cambridge, MA, United States
Jul 21, 2021
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Why Join Intellia?

Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.

We want all of our people to go beyond what is possible. We aren't constrained by typical end rails, and we aren't out to just treat people. We're all in this for something more. We're driven to cure and motivated for change. Just imagine the possibilities of what we can do together.

How You Will Achieve More With Intellia:

We are excited to welcome this new member to our growing QC team and company . As a Senior Quality Control Associate, you will be supporting Intellia's stability and reference standard programs, engaging with our external clients to move products through clinical development. In addition, you will serve as a liaison for cross-functional workstreams across Analytical Development and Quality Assurance. You'll have opportunities to participate in various projects and initiatives in addition to these primary responsibilities:
  • Perform review of QC stability data in support of GMP clinical trial material in compliance with SOPs. Compile and trend stability data and reports. Update regulatory submission content.
  • Coordinate internal and external testing activities including sample management and shipments.
  • Track work orders, purchase orders, and invoices, to ensure continuity of testing.
  • Initiate and author technical memos, change controls, deviations, and CAPAs.
  • Assist in the implementation and maintenance of general lab operational systems in accordance with GxP compliance to maintain functionality.
  • Serve as the cross-functional team member for assigned projects.

About You:

Do you consider yourself organized and detail-oriented? Are you skilled at communicating key updates to stakeholders? If so, then this is the role for you.
  • Bachelor's degree with 4-6 years' GMP lab experience
  • Experience conducting testing and reviewing QC data in support of GMP
  • Knowledge of a variety of methods, including but not limited to: HPLC, UV, CE, Bioassay, gel electrophoresis, and compendial testing
  • Technical writing experience including creating, revising, and reviewing SOPs, protocols, reports, technical assessments, and technical memos
  • Knowledge of the use and interpretation of pharmacopeias such as USP/NF, EP, and JP
  • Knowledge and experience with electronic systems such as EDMS, LIMS, etc. preferred
  • Ability to manage multiple competing priorities

About Your Future Team:

The Quality Control team is a self-motivated and lively group, with an innate curiosity to learn. The QC department supports release and stability testing for GMP products throughout the product life cycle. This role interacts with QC Operations and QC Tech Services as part of the expanding Quality team.

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.