We are powering the age of immune medicine- you can too. At Adaptive, our goal is to meaningfully improve people’s lives by learning from the wisdom of the adaptive immune system.
As an Adapter, you will be surrounded by driven colleagues who think boldly to pursue ground-breaking innovation. You will experience meaningful challenge in your work and be fueled by motivating energy knowing you make a difference in people’s lives.
You belong here- come discover your story at Adaptive.
This position supports Quality and other Adaptive Departments by organizing, maintaining and tracking documents in an electronic Quality Management System for the full lifecycle of the document.
Follow Adaptive Documentation standards, guidelines and processes; provide input for future updates.
- Review documents in the Quality Management System (Reliance)
- Verifies a document is ready for final approval by ensuring proper review has been completed, property requirements have been met, document is on the current effective template, and relationship have been created correctly
- Manages the obsoletion process for documents and records as requested by the document owner
- Monitors/manages the periodic review process for specified GMP documents
- Tracks and trends outstanding Document Control requests. Provides periodic status reports and performance metrics to supervisor and/or Adaptive management.
Manage backlog of manuals and documents for archiving.
- Process documents for archiving according to the Adaptive Records Retention requirements.
- Receive new documents and file/store as necessary.
- Scan hard copy documents for electronic storage as needed.
- Track checked out documents and re-file returned materials.
Supports other related quality record systems and databases such as training, change control, deviations, CAPA, and reports.
- Associates degree
- 2+ years of relevant experience
- Ability to communicate effectively, verbally and in writing, and demonstrate good interpersonal skills interdepartmentally and with external vendors and contractors.
- Technical writing experience or experience writing technical manuals and procedures.
- Strong understanding of US Quality System Regulations (QSR) and 21CFR Part 11.
Adaptive Biotechnologies is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Equal Opportunity Employer/Veterans/Disabled