Quality Systems Associate

Position Overview

The Quality Systems Associate will work with new and 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. The position will apply quality systems knowledge, reasoning, and judgment skills to ensure an appropriate balance of quality, compliance, and business needs are being consistently met.

Responsibilities

• Review quality systems policies and procedures, and perform revisions
• 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 with 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

Required

• Bachelor’s Degree in a relevant scientific discipline
• 3+ years demonstrated experience performing Quality Assurance in an FDA-regulated medical device industry environment (knowledge of ISO 13485 and 21 CFR 820)
• 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)

Preferred

• Working knowledge of CLIA and CAP regulations
• CLIA laboratory experience
• Prior work with IVDs, molecular diagnostics, PCR-based assays, and/or sequencing technologies
• GMP knowledge
• Technical background with methods and protocols knowledge

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

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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.