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Development:
Senior Associate, QA – Ex Vivo
At Intellia, we are revolutionizing medicine by harnessing the power of genome editing to develop potential cures. We bring new hope for people living with conditions including cancer, genetic disorders, viral infections, inflammatory disorders and many more.
Intellia Therapeutics has an exciting new opportunity for a Quality Assurance Senior Associate. In this role you will provide compliance support to our emerging ex vivo programs. You will support day to day Quality related activities and will act as a liaison to cross-functional groups including Process Development, Analytical Development, Quality Control, and Regulatory Affairs.
Responsibilities:
- Assist in the implementation of GxP quality standards, policies, and procedures.
- 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
- Support equipment validation activities including document generation, review, and approval.
- Participate in internal audits and ensure that related follow-up activities are performed.
- May assist in the development of training programs.
- Prepare metrics for presentation to management.
- Participate on contract organization project teams as required.
- Support electronic quality system implementations.
Qualifications:
- Experience at working both independently with minimal supervision and in a team-oriented, collaborative, environment.
- Ability to analyze a wide variety of information and data to assist with management decisions regarding potential risks associated with regulatory compliance.
- Effective writing and oral presentation skills.
- 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)..
- Experience working with electronic quality systems (e.g. eDMS, QMS).
- Experience in developing Quality Assurance procedures.
#LI-KO1
What Intellia Stands For:
At Intellia, our mission is to develop potentially curative genome editing treatments that can positively transform the lives of people living with severe and life-threating diseases.
We push boundaries. We are focused on positively disrupting health care treatment of patients with genomic diseases. The values we live by and drivers we look for are:
- One is respect for individuals; our unique qualities and strengths; our own ways to understand, learn and improve. One is our single-minded determination to excel; to succeed together. One is you and us – trusting and counting on every single one of us.
- Explore because we seek new ways to tackle disease. Explore with unbounded minds…free from assumptions, open to ideas. Explore by staying curious, by pushing boundaries, overcoming obstacles. Explore means thinking of new ways.
- Disrupt by thinking courageously…and creating a better future. Disrupt by defying conformity; interrogating the status quo; questioning our momentum. Disrupt with challenging thoughts…with that breed of skepticism that shows you have better solutions.
- Deliver with your focus on the objective and your determination to complete the task. Deliver by advancing relentlessly and by maintaining high standards…even when nobody is watching. Deliver by staying accountable and pulling your weight. Deliver because patients are counting on us to make the promise reality. Get it done.
POSITION: Full-Time, Exempt
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.
Intellia’s web-based application process is managed through Lever. Information submitted through application forms is collected by Lever and subject to Lever’s privacy policy.
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.