ARE YOU ADAPTIVE? We’re driving groundbreaking research in cancer and other immune-mediated diseases that translates into novel clinical diagnostics and innovative therapeutics. We are at the forefront of immune-based discoveries, transforming the future state of health through our disruptive, proprietary immunosequencing technology. With strong financial footing and rapid growth, we are looking for the brightest, most passionate and collaborative innovators to join us.
At Adaptive, you'll be challenged, you'll be inspired, and you'll be proud to be part of an innovative organization making a real impact on improving the quality of life globally. No matter what your role is, you'll find a diverse, team-driven, fun culture where your contributions truly count. #BeingAdaptive
The Senior Quality Systems Specialist will work with new or transferred products to administer quality system elements to ensure regulatory compliance and robust product/process design. The position is accountable for the applications of industry standard quality practices and tools as applied by Adaptive Biotechnologies. The role requires the ability to manage priorities from multiple projects and tasks utilizing effective written and oral communication skills. Will apply quality systems knowledge, reasoning and judgment skills to ensure the appropriate balance of quality, compliance and business needs.
- Develop quality systems policies and procedures, and perform revisions and periodic reviews
- Evaluate and ensure completion and closure of change control records
- Provide QA input to functional groups to evaluate and ensure proper closure of deviations, investigations, complaints and CAPAs
- Execute on supplier qualification activities such as Supplier Corrective Action Requests, performing supplier audits and writing audit reports
- Assist with internal audits
- Support regulatory and third-party inspections
- Follow up on actions related to audit observations
- Interact with lab operations personnel to ensure compliance to company quality systems policies and procedures
- Review manufacturing and testing documentation including validation/qualification, batch records, and other technical documents. Support final review and release of material produced in-house and at contract manufacturers.