Adaptive Biotechnologies – Clinical Lab Quality Compliance Specialist II – Seattle, WA

Job title: Clinical Lab Quality Compliance Specialist II Company: Adaptive Biotechnologies Job description: Position Overview The Clinical Lab Quality Compliance Specialist II takes ownership of quality assurance (QA) and continuous quality improvement (CQI) activities in the Molecular Laboratory Operations (MLO) group at Adaptive Biotechnologies' Seattle laboratory. The primary function of this role is to ensure CLIA/CAP/NYSDOH compliance, and support overall regulatory compliance within the high-complexity clinical laboratory. Key Responsibilities and Essential Functions

• Participates with team to champion culture of Quality within the Clinical Laboratory Operations at Adaptive.
• Supports the Clinical Laboratory Director (CLD) and MLO leadership by supporting and championing initiatives specific to CAP/NY clinical laboratory compliance, with a focus on CQI.
• Adopts and implements new KPIs for compliance monitoring of overall clinical quality, operational performance, and staff training/competency; monitors dashboards regularly for signals and escalates appropriately when necessary
• Collaborates with teammates, MLO staff and the QA team to facilitate timely resolution of nonconformance, CAPA and deviations including assessment of sample impact/risk, blockers and project dependencies, managing personnel follow-up to ensure timely resolution and proper documentation; manages notifications to internal/external partners as needed.
• Leads stakeholders on periodic quality assessments, as required by CAP/CLIA/NY regulations; generates quality indicator data and related presentations or reports for the CLD
• Facilitates quality improvement initiatives related to quality indicator performance and overall clinical laboratory compliance
• Ensures new MLO employee personnel records are collected and maintained in document control systems, and completed for CLD annual review per compliance requirements
• Expert in nonconformance, deviation, and CAPA management including assessment of blockers and project dependencies, and managing personnel follow-up to ensure timely resolution
• Supports timely resolution of change controls and audit management tasks by managing follow-up and resolutions with responsible individuals, considering relative value of several alternative solutions to potential actions before confirming with stakeholders a final decision as to the path forward
• Administrative tasks are completed on time, including site license renewals (CAP, NY and other state departments of health), or other assignments by the Associate Director, Technical Operations or CLD
• New MLO employee personnel records are collected and maintained in document control systems, and completed for CLD annual review per compliance requirements
• Other compliance-related projects as assigned by the Director, Molecular Lab Operations and CLD.
• Regulatory responsibilities (when delegated) of “Laboratory Director” for high complexity testing as defined by 42CFR493.1451*

• Regulatory responsibilities per Good Clinical Practices (GCP)

• Regulatory responsibilities per Good Laboratory Practices (GLP)

Position Requirements Required

• Bachelor of Science degree from an accredited university in a biological related field or the equivalent with 5+ years of related experience; 3+ years with Master of Science degree.
• Preferred 2+ years within any of the following: GxP/CAP/CLIA/NYSDOH-certified environment within a high-complexity clinical laboratory (NGS, HPLC, Mass Spectrometry, Flow Cytometry) or equivalent regulatory/testing environment
• Proficient in CLIA/CAP/NYSDOH/GMP/GCP/GDP/GCLP/GLP regulations and standards
• Minimum of 1 year of experience working within Quality Management Sytems. (e.g. deviations, CAPA, Nonconformances, complaints, Good Documentation Practices.)
• Proficient in MS Office, particularly Excel and PowerPoint, and routine office software applications such as email
• Ability to follow and champion Good Clinical and Laboratory Practices, including Good Documentation Practices
• A willingness to champion Continuous Quality Improvements (CQI)
• Demonstrated ability to manage complex projects and work effectively across functional areas
• Inquisitive by nature; comfortable asking team and supervisors for help
• Excellent organizational and time-management skills
• Superior oral and written communication skill

Preferred

• National certification (e.g., ASCP, ASQ, etc)
• CAP inspector
• Prior experience as a medical technologist or laboratory associate in a regulated laboratory, preferably as an SME or team lead or supervisor of NGS testing or relevant high-complexity laboratory testing.
• High integrity and experience with HIPAA compliance
• High attention to detail
• Results and solution-oriented
• Team player
• Demonstrated ability to problem-solve in a fast-paced dynamic organization
• Demonstrated ability to initiate and complete projects
• Demonstrated ability to work cross-functionally with other teams
• Experience and proficiency with LIMS systems, Tableau data systems and web-based applications

Working Conditions Work in a clinical laboratory environment. May require entrance to laboratory. Hybrid work conditions preferred, open to remote (WFH). If WFH, must have high speed internet connection suitable for sustained video conferencing. Expected to be “on-camera” for majority of meetings. Physical Requirements Prolonged periods of working at a computer. Expected salary: Location: Seattle, WA Apply for the job now! Apply tot his job Apply To this Job