Intellia Therapeutics Cambridge , MA 02138
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.
Reporting to the Director of Quality Assurance, the Document Control Specialist is responsible for administrative support of the GxP quality systems. Activities will include but are not limited to document management (including processing, review, numbering, issuance and archival), metrics compilation, and training as well as supplier quality program support. Participates in independent and team projects as required.
PRIMARY DUTIES (including but not limited to the following)
Facilitates workflows of GxP documents (including but not limited to SOPs, Batch Records, Test Methods, Protocols, Reports, Specifications, etc.).
Provides day-to-day support of the electronic document management system, and operational controls to maintain the validated state (compliance with 21 CFR Part 11)
Prepares and inspects documents for scanning operations, scans and re-assembles documents
Maintains employee training files both electronic and hard copy. Ensures employee training documentation is in accordance with regulatory requirements.
Assist with maintenance of quality systems including deviations, investigations, change controls, etc.
Assist with metrics generation for Quality management
Prepares documentation for internal audits
Tracks and updates internal supplier-related records
Assigns unique identifiers to quality-related documentation
Maintains equipment history files
KEY SKILLS, ABILITIES & COMPETENCIES
Possess strong computer and Internet skills, including online document management experience and proficiency in Microsoft Office (Outlook, Excel, Word, & PowerPoint)
Highly organized with a strong attention to detail
Effective writing and oral presentation skills.
Experience at working both independently and in a team-oriented, collaborative environment
Ability to work within rapidly changing environment and to quickly adapt to new situations.
EDUCATION & EXPERIENCE REQUIREMENTS
AS/BS/BA degree and 0-2 years of relevant Quality Assurance work experience in a GMP regulated environment
Prior experience with Electronic Document Management Systems preferred
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 mindsfree from assumptions, open to ideas.
Explore by staying curious, by pushing boundaries, overcoming obstacles. Explore means thinking of new ways.
Disrupt by thinking courageouslyand creating a better future. Disrupt by defying conformity; interrogating the status quo; questioning our momentum. Disrupt with challenging thoughtswith 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 standardseven 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.