Clinical Quality Assurance Specialist IV

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. These values are grounded in and expressed through the principles of diversity, equity and inclusion. 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. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.

 

The Clinical Quality Assurance Specialist IV is a member of the clinical quality team and provides quality support to ensure compliance with industry standards and regulations. This position reports to the Quality Lab Operations Manager.

PRIMARY/ESSENTIAL DUTIES:

• Implements, maintains, and monitors all aspects of the comprehensive quality program in support of molecular oncology CLIA lab operations.
• Provides leadership and guidance to junior lab members. Directs work of junior staff.
• Provides guidance and assistance to CLIA staff on various aspects of the quality program.
• Maintains and employs the document control system, including maintenance of internal procedures, contractual requirement documents and ensuring that document change requests and biennial reviews of documents are facilitated and implemented within a timely manner.
• Develops, reviews and revises internal procedures and other quality documents, as needed. Acts as document owner or signatory identity for quality related system documentation, when appropriate.
• Maintains and implements the employee SOP training program and system, including providing new employee orientation, assigning training to staff members, maintaining the, training system, master training files and monitoring progress. Develops and facilitates quality related specialty training to administrative and technical staff, as identified by need.
• Supports CLIA validation efforts by ensuring that appropriate documentation is generated, that target dates are established, that the process remains on schedule, that documents are complete and accurate and that validation documentation is properly archived.
• Leads, implements and maintains the internal audit program and system. Develops the internal audit schedule, performs internal audits and related monitoring and follow up activities.
• Ensures that change control procedures are followed with regards to controlled documents. Schedules and leads change control meetings and provide follow up activities, as needed.
• Implements and maintains the deviation and corrective and preventative action (CAPA) program, including conducting root cause analysis, trending, monitoring and coordination of interdepartmental corrective action and preventive activities.
• Assists and/or leads the execution of client surveys, responds to client concerns and questions, as well as, implements follow up activities, as well as, documents events.
• Develops and facilitates internal and external presentations, when required.
• Keeps management and stake holders abreast of quality related activities. When requested, develops metrics and conducts trending analysis for reporting purposes.
• May provide input for performance evaluations for junior CLIA staff.
• Manages and leads projects and quality related activities. Interacts with cross- functional teams on projects and other activities.
• Attends, organizes, leads, guides and participates in meetings, as needed. Acts as quality representative.
• Assists CLIA management and stake holders in preparation of onsite audits/inspections and in facilitating corrective actions, as applicable. Assists in activities to prepare units, departments and personnel to be inspection ready.
• Participates in regulatory inspections, third party client audits and responding to client questionnaires and inquiries, as assigned. Includes preparing audit summary reports, responses to observations and monitoring of corrective action activities.
• Interfaces with existing and potential clients.
• Represents company at professional meetings and/or training.
• Performs other tasks as assigned by the Quality Lab Operations Manager and/or CLIA Senior Management.
• Other duties as assigned.

SCOPE OF RESPONSIBILITY:

• Level of autonomy
  • The Clinical Quality Assurance Specialist IV will work with lab management and the quality team to develop, implement, maintain and monitor all aspects of the comprehensive quality program in support of Molecular Oncology CLIA lab operations.
  • The Clinical Quality Assurance Specialist IV assists with directing and mentoring junior quality staff, leads quality activities, provides technical direction and oversees the work performed on those activities.

MINIMUM QUALIFICATIONS:

• Bachelor’s degree with direct experience implementing and leading a comprehensive quality system in a regulated environment.
• 5 years of direct experience in the following quality assurance activities:
  • Implementing and managing a document control system (regular review and development of SOPs).
  • Assigning and tracking training for all staff (development of training materials and facilitating training to staff).
  • Managing an internal audit program (schedule, facilitate, document and track internal audits).
  • Managing and tracking a comprehensive CAPA program (work with CAPA owners and managers to develop appropriate documentation, investigate issue, recommend appropriate corrective and preventative actions, and monitor effectiveness).
  • Hosting client audits and/or regulatory inspections (scheduling, documenting, reporting and responding to observations and questionnaires).
  • Review of system validation documentation.
  • Management and implementation of projects as part of the continuous quality improvement process.
• Must have current ASCP license, either MB or MLS.
• Must have working knowledge of Good Clinical Practices (GCP) relating to clinical trials.
• 7+ years of progressive experience in implementing quality systems may substitute educational requirement.
• Must meet the minimum requirements for a Quality Assurance Specialist III.
• Must be detailed oriented with ability to maintain accurate digital and paper records.
• Strong organizational and multi-tasking skills are required, as are excellent verbal and written communication skills.
• Must have working knowledge of Good Clinical Practices (GCP) relating to clinical trials.
• Knowledge of lab safety and sterile technique.
• Proficiency in MS Office applications is essential.

PREFERRED QUALIFICATIONS:

• 2 years of experience in a senior, lead or supervisory quality role.
• Compliance and regulatory experience with DOH, CLIA, CAP.
• Document control: developing procedures, maintaining and implementing a document control system.
• Internal auditing.
• Deviation and CAPA reporting.
• Regulatory inspections and Third-party client audits.
• Quality metrics, trending.
• Change control.
• Document and archive management.
• Continuous improvement efforts.

DEPARTMENT SPECIFIC ADDENDUM:

• Requires adherence to internal SOPs and applicable regulatory requirements, as well as, ability to encourage and ensure compliance among others.
• Requires timely completion of deliverables and and reports.
• Requires ability to work independently or in a team environment.
• Requires ability to work independently with minimal supervision.  
• Excellent interpersonal skills and excellent written and oral communication skills to explain concepts.
• Strong organizational skills and the ability to maintain accurate and detailed records.
• Requires ability to interact efficiently, cooperatively and professionally with all functional team members and other CLIA staff, as well as, outside clients and vendors.
• Requires the ability to exercise good judgment and the ability to prioritize activities, as well as, manage multiple projects and activities, many with strict deadlines.
• Requires ability to lead and guide meetings.  
• Requires ability to lead project activities and ensure deliverables are met within an established time frame.
• Requires ability to mentor, lead, and guide junior staff. 
• Requires the ability to facilitate formal and informal presentations and training in group settings.
• May require ability to travel on long or short term business trips.
• May require occasional long hours, weekend or holiday hours, as needed to complete time-sensitive activities.
• Requires ability to read, write and speak English.

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A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

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The annual base salary range for this position is from $97,552 to $154,148, 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). 

We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to Human Resources at hrops@fredhutch.org or by calling 206-667-4700.