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Lead, Quality Control

Company: Intellia Therapeutics
Location: Cambridge
Posted on: April 8, 2021

Job Description:

Intellia Careers Lead, Quality Control Cambridge, MA 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. Summary:-- Intellia Therapeutics has an exciting new opportunity for a Lead in Quality Control. In this role you will have the opportunity to support the activities related to testing performed at contract organizations. In addition to coordinating testing related activities, you will support Quality Events and efforts for new product implementation. You will act as the interdepartmental liaison to cross-functional groups including Analytical Development and Quality Assurance. Responsibilities: Primary s upport of batch release, test methods, and new product implementation . Perform data review, statistical analysis, and trending. Conduct assessments of laboratory investigations and quality system events, including authoring deviations, CAPAs, and change controls. Support implementation and maintenance of general QC operational and electronic systems in accordance with G x P compliance to maintain functionality. Troubleshoot and provide additional technical support for method, material, and instrument-related issues. Cross-functional team member for assigned projects. Qualifications:-- B achelor's de g ree with minimum of 8 years' GMP QC experience. Ability to effectively resolve technical issues using a variety of bioanalytical methods, including but not limited to: HPLC, CE, MS , gel electrophoresis , and compendial tests .-- Experience in analytical techniques such as PCR, bioassay, and ELISA is desirable . Experience with CMO Management Knowledge of the use and interpretation of pharmacopeias such as USP/NF, EP, JP. Experience conducting testing and reviewing QC data in support of GMP. Ability to conduct investigations , deviations, change controls. Experience with method troubleshooting . Technical writing experience including creating, revising, and reviewing SOPs, protocols, reports, technical assessments, and technical memos. Detail - oriented with the ability to manage multiple , competing priorities. Strong verbal and written communication skills. Knowledge of method transfer, qualifications, and validations, preferred Knowledge and experience with electronic systems such as EDMS, LIMS, etc ., preferred. 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. Posted 6 Days Ago Full time R78 About Us 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.

Keywords: Intellia Therapeutics, Cambridge , Lead, Quality Control, Other , Cambridge, Massachusetts

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