Quality Assurance Specialist I - Clinical Lab Quality

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world's leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world's deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems.

The Clinical Lab Quality Department providers quality assurance oversight to the Alliance Lab (including Satellite Labs), Pathology Lab, Point of Care Testing (POCT) Program, Cellular Therapeutics Labs (CAP accredited testing only), Clinic Immunogenetics Lab, Clinical Cancer Genomics Lab, Pharmacokinetics Lab and all Fred Hutch operated Community Site Laboratories. The laboratories are accredited by the College of American Pathologists (CAP) or the American Society of Histocompatibility and Immunogenetics (ASHI) along with various other state and laboratory specific organizations. POCT may be accredited by CAP, WA DOH or covered by the TJC Waived Testing Standards. All lab sites are required to follow pertinent rules and regulations as required by hospital licensing and accreditation by WA DOH and TJC. Additionally, all laboratories are expected to follow all expectations outline by CLIA and all laboratories performing Lab Developed Tests (LDTs) are required to follow applicable FDA laws and regulations

Under the direction of the Senior Quality Assurance Manager - Clinical Laboratories, this role contributes to and supports the Quality department in the review of controlled documents, auditing of processes, quality systems and support of quality improvement efforts related to compliance and daily operations of the Quality Department. The Quality Assurance Specialist I is responsible for representing the Quality department on Operational led project teams; providing regulatory and accreditation standard insight in support of the project goals and deliverables; responsible for CLQ's regulatory and accreditation continuous readiness programs.

Oversee development and implementation of quality systems to assure compliance with relevant standards and regulations; specifically, but not limited to, CLIA/CAP/ASHI/FDA/DOH/TJC.
• Provide QA support for equipment, test method and process validations and review protocols and reports.
• Author, review and qualify controlled documents such as standard operating procedures (SOPs) to achieve compliance with regulatory and accreditation requirements. Provide guidance to the Operational staff/management to improve compliance with requirements with CLIA/CAP/ASHI/FDA/DOH/TJC.
• Support inspection preparation and hosting activities for accreditation/regulatory bodies such as, but not limited to CLIA/CAP/ASHI/FDA/DOH/TJC.
• Support ongoing communication of regulatory standards to employees and management with emphasis on functional importance of compliance with regulation and guidelines.
• Assess potential gaps or areas of non-compliance with current standards/regulations; and escalate as appropriate to Leadership.
• Work with Operational management in staff training development and oversee the implementation and management of an on-going quality training system.
• Lead complex investigations of issues related to product quality. Perform root cause analysis, identify issue(s) and potential corrective and preventive actions.
• Lead implementation of multi-displinary process improvement projects as a Quality Subject Matter Expert, including developing future state processes design, SOP development and review to support the new process.
• Provide support to multidisplinary teams to address quality and compliance requirements. Act as a quality liaison providing guidance and expertise to the teams as necessary.
• System owner or resident expert of one or more CLQ systems/functions such as, but not limited to, CAPA, serious adverse reaction investigation, MediaLab (one or more modules), Lab QI Committee/Dashboard Support, Regulatory Audit Program.
• Perform audits of areas or systems impacting Quality. This may include writing and presenting the final audit report.

Required

• B.S. degree with a major in biological science, medical technology or related discipline; or equivalent combination of experience and education

• Minimum 5 years of relevant experience in a regulated clinical laboratory environment and/or experience in quality assurance management.

• Ability to interpret applicable regulations (CLIA/CAP/ASHI/FDA/DOH/TJC), working knowledge of cGTP, cGMP, FACT not required
• Working knowledge of cGTP, cGMP and related FDA regulations
• Proven ability to interact constructively with all levels of staff and facility; as well as outside contacts
• Experience with performing investigations
• Experience with performing audits
• Experience with computer databases including statistical software and competent with MS Office Programs
• Experience with project management or project oversight
• Expertise in planning, managing, and coordinating work teams and defining work products
• Excellent interpersonal skills
• Proven ability to multi-task and strong attention to details and accuracy

Preferred

• Masters in relevant field
• Regulatory/Technical writing skills and experience
• Experience working in an FDA regulated environment
• Certified CAP Inspector Team Member
• Excellent technical writing skills.
• Working Knowledge of FACT, CAP, and The Joint Commission standards
• Working knowledge of complex IT systems, Laboratory Information Systems and Part 11 compliance
• Understanding of statistics

The annual base salary range for this position is from $86,985.60 to $130,457.60 and pay offered will be based on experience and qualifications.

Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months).