QA Senior Associate

Location
Cambridge, MA, United States
Posted
Jan 08, 2021
Ref
R9
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Our Mission: Developing curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

At Intellia, we are committed to solving the complex challenges of making CRISPR/Cas9-based medicines a reality for patients suffering from genetic diseases and to create novel engineered cell therapies for immuno-oncological and autoimmune diseases.

Job Description:

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.