QA Senior Associate

Location
Cambridge, MA, United States
Posted
Feb 05, 2021
Ref
R61
Hotbed
Genetown
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 at Intellia:

Intellia Therapeutics has an exciting new opportunity for a Quality Assurance Operations Senior Associate. Reporting to the Senior Manager of Quality Assurance, you will provide compliance support to manufacturing and testing activities for internal development teams as well as at contract organizations. You will act as a liason to cross-functional groups including Quality Control, External Manufacturing, and Supply Chain.

Responsibilities:
  • Review batch records and data in support of drug substance and drug product release activities
  • Perform activities related to Quality events such as change controls, deviations and CAPAs
  • Support method transfer and qualification activities including protocol and report review and approval
  • Participate in internal audits and ensure that related follow-up activities are performed
  • Participate on contract organization project teams as required
  • Assist in the implementation of GxP quality standards, policies and procedures
  • Prepare metrics for presentation to management
  • Support electronic quality system implementations


Qualifications:
  • BS in a related scientific field with 5+ years of Quality experience in a GMP regulated environment
  • Working knowledge of regional regulatory requirements specific to GMPs (e.g. FDA, EU)
  • Proficiency in MS Office applications (Word, Excel, Powerpoint, Project) and Quality System Databases
  • Effective writing and oral presentation skills
  • Experience at working both independently with minimal supervision and in a team-oriented, collaborative environment
  • Ability to analyze issues and resolve in a compliant manner
  • Experience working with electronic quality systems (e.g. eDMS, QMS) is a plus
  • Experience in developing Quality Assurance procedures is a plus


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.