Clinical Lab Quality Compliance Specialist I

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Position Overview

The Clinical Lab Quality and Compliance Specialist I supports quality assurance (QA) activities in the Molecular Laboratory Operations (MLO) group at Adaptive Biotechnologies’ Seattle laboratory. The primary function of this role is to support completion of CLIA/CAP/NYSDOH compliance activities and related projects 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.
• Works with subject matter experts within the clinical laboratory to demonstrate ongoing compliance by compiling and presenting metrics related to overall laboratory performance, such as daily/weekly/monthly operational metrics, non-conformances, and process improvement efforts.
• Maintains metrics dashboards for use by MLO management; sees and recommends improvements or optimization suggestions to management
• Regularly informs CLD and VP of MLO with NC and INCT meeting certain criteria, as directed by laboratory management
• 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.
• Appropriately raises concerns to management regarding quality issues
• Analyzes trends in nonconforming events, identifies opportunities for continuous quality improvement, and triggers CAPAs as warranted. Escalates project opportunities to department leadership
• Participates as a member of a project team, representing regulatory compliance and quality
• Facilitates continuous quality improvement initiatives with MLO management and the Quality team
• Works closely with Clinical Laboratory management to use system tools for documenting and monitoring training, competency and continuing education of the laboratory staff; assists managers with tracking, scheduling and documenting as needed
• Supports state licensing (NY, CA, etc.) and CAP accreditation renewals
• Supports regulatory submissions for NYSDOH assay approvals
• Ensures that personnel records for new MLO employees are collected and maintained in document control systems, and completed for annual review by the Clinical Laboratory Director (CLD) per CAP/NY requirements
• Supports metrics gathering and generates presentations for periodic quality assessment of the clinical laboratory by the CLD as required by CLIA/CAP/NYSDOH regulations; interfaces with QA and MLO team to ensure follow up on corrective actions
• Supports Production team managers/supervisors in other QA initiatives to ensure laboratory compliance with applicable regulations.
• Performs administrative tasks as directed by the Associate Director, Technical Operations or the CLD
• Supports the corporate QA team during external audits
• 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

• BS degree from an accredited university in a scientifically related field or the equivalent
• 2+ years experience in regulated healthcare environment (e.g., GxP/CAP/CLIA/NYSDOH/HIPAA in a clinical laboratory such as NGS, HPLC, Mass Spectrometry, Flow Cytometry or equivalent regulatory/testing environment) (0+ with Master of Science degree)
• Proficiency in MS Office, particularly Excel and PowerPoint, and routine office software applications such as email
• A willingness to learn and work towards Continuous Quality Improvements (CQI)
• Detail Oriented
• Excellent organizational and time-management skills
• Superior oral and written communication skills
• Demonstrated ability to manage complex projects and work effectively across functional areas
• Inquisitive by nature; comfortable asking team and supervisors for help

Preferred

• Experie