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 Software Quality Assurance Associate is responsible for supporting, and may have individual responsibility, for implementing and maintaining the effectiveness of the quality system for the development of product and process software. The position is accountable for the applications of industry standard software quality practices and tools as applied by Adaptive Biotechnologies. The position 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 and maintain departmental operating procedures and policies to ensure compliance to relevant FDA quality systems regulations, ISO guidelines, including 21CFR Part 11 and Adaptive requirements as they relate to the development, validation and maintenance of computerized systems used in the quality system
- Review SDLC documentation for accuracy, clarity, consistency, completeness and compliance for multiple projects. Including software specifications/requirements documents, validation protocols, trace matrices and validation reports
- Evaluate and ensure completion and closure of software change control records
- Provide SQA input to functional groups to evaluate and ensure proper closure of deviations, investigations, complaints and CAPAs
- Assist with computerized systems internal audits
- Support regulatory and third party inspections related to computerized systems
- Follow up on actions related to audit observations
- Bachelor’s degree in a relevant scientific disciple
- 5+ years of experience in Software QA in an FDA-regulated medical device industry
- Prior work with IVDs, molecular diagnostics, PCR-based assays, sequencing technologies and/or CLIA laboratories is highly desirable
- Strong working knowledge of ISO 13485 and 21 CFR 820
- Experience working with software development teams
- Exercises judgment within well-defined and established procedures and practices to determine appropriate action
- Ability to work independently and in a team environment
- Detail-oriented with good organization and time management skills
- Strong interpersonal and verbal/written communication skills
- Able to respond quickly to shifting priorities and to meeting deadlines
- Proficiency with Microsoft Office tools (Excel, Word, and PowerPoint)
Salary is commensurate with experience and qualifications. Excellent benefits package including employer paid medical, dental, vision, vacations and holidays for eligible positions.
Adaptive Biotechnologies Corp. 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.
NOTE TO EMPLOYMENT AGENCIES: Adaptive Biotechnologies values our relationships with our Recruitment Partners and will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us. Adaptive Biotechnologies is not responsible for any fees related to resumes that are unsolicited or are received by any employee of Adaptive Biotechnologies who is not a member of the Human Resources team.