The Department of Laboratory Medicine & Pathology at the University of Washington in beautiful Seattle is actively seeking a full-time, day shift Quality Assurance Specialist for the Virology Division.
SALARY: $5,943 - $8,914 per month
WHAT YOU'LL DO:
Quality Management (QM) Programs, including Quality Improvement program and QA/QC Procedures for Clinical Trials:
- Participate with faculty and managers in the development, implementation and maintenance of QM programs.
- Responsible for development, updating and regular review of policies and standards.
- Assess the accuracy and adequacy of documentation against regulatory requirements.
- Develop and maintain a strong audit and monitoring program.
- Analyze data and prepare reports.
- Demonstrate a thorough working knowledge of QA/QC procedures.
- Demonstrate technical competencies, knowledge and ability to conceptualize, plan and support the QA/QC for new technologies, programs and services.
- Demonstrate knowledge and practice of efficient, customer focused operations.
- Demonstrate the ability to work within a matrix environment.
Auditing and Corrective Action:
- Work with Faculty and managers to develop and maintain a system of regular QA/QC monitors and audits to assure that the laboratory standards are being met.
- Serve as main point of contact for inspections and audits for clinical trials or clients.
- Risk assessment and risk mitigation.
- Conducts investigations of QA/QC failures as necessary; documents findings.
- Demonstrates effective and appropriate critical thinking skills and decision-making abilities consistent with UW Medicine and Laboratory Medicine's missions and values.
- Demonstrates professional and effective verbal and written communication skills.
- Collaboratively establish corrective action plans.
- Seeks feedback and makes constructive changes as a result.
- Open to receiving direction and asks for assistance when needed.
Records and Data Management:
- Collaborate, monitor, and audit data transfer of results to ensure privacy, confidentiality, and security of patients and study data.
- Responsible for document management of records, raw data and source data and document retention processes to meet clients requirements and expectation.
- Monitor and audit data for system quality and compliance is meet for downstream clinical trial test systems, including validating data produced by new interfaces and performing on-going downstream result validation on data per contractual requirements.
QA/QC Training and Education:
- Create training and education material all staff involved in clinical trials on GCP, GLP, and GDP.
- Train from materials developed and best practices to all staff involved in clinical trials on GCP, GLP, and GDP.
- Assess competency assessment for all levels of testing staff involved in clinical trials are documented, re-train as appropriate.
- Monitor to ensure training requirements are satisfied as appropriate.
- Participate in development and implementation of MediaLab document control system at the department level.
- Lead division staff and provide continuing direction to division after implementation.
- Participate with faculty and managers in the establishment of consistent document control processes throughout the division.
Proficiency Testing (PT) Program:
- Work with Faculty and managers to develop and maintain the proficiency testing program.
- Main point of contact for all proficiency testing, including completion of proficiency testing paperwork, obtaining proper signatures, and ensuring PT program meets CAP requirements.
WHAT YOU'LL NEED:
- Bachelor’s Degree in Medical Laboratory Science or related field
- Medical Laboratory Scientist with current ASCP certification
- In-depth understanding of quality management concepts and regulatory/accreditation requirements.
- 4-5 years laboratory experience
- Proficiency with WORD and EXCEL
- Self-motivated and directed
- Detail oriented and highly organized
- Must be able to communicate clearly in English, both written and verbal
WHAT WE OFFER:
Competitive Benefits | As a UW employee, you will enjoy generous benefits including, but not limited to:
- Medical, dental, disability, and life insurance coverage
- Medical flexible spending account options
- Retirement plan options
- Paid time off, including vacation, sick, and holiday time
- Tuition reimbursement
- Work/life programs
- Fully subsidized U-PASS for public transit
A higher degree of healthcare.
All across UW Medicine, our employees collaborate to perform the highest quality work with integrity and compassion and to create a respectful, welcoming environment where every patient, family, student and colleague is valued and honored.
The Department of Laboratory Medicine & Pathology serves as a regional resource for clinical laboratory services required for patient care, research and educational programs in laboratory medicine. The department currently employs 1800 people who work at the award-winning University of Washington Medical Center (ranked among the top medical centers in the United States as rated by U.S. News & World Report), Harborview Medical Center (the region's only Level I Trauma center, known for innovations and excellence in trauma care and its centers of emphasis: Trauma, Burn, Neurosciences, AIDS/STD CARER, and mentally- and medically- vulnerable populations.), and many other clinical and research facilities in the area. The University of Washington (UW) is proud to be one of the nation’s premier educational and research institutions. Our people are the most important asset in our pursuit of achieving excellence in education, research, and community service. Our staff not only enjoys outstanding benefits and professional growth opportunities, but also an environment noted for diversity, community involvement, intellectual excitement and natural beauty.
UW Medicine includes Harborview Medical Center, UW Medical Center - Montlake, UW Medical Center - Northwest, Valley Medical Center, UW Neighborhood Clinics, UW Physicians, UW School of Medicine, and Airlift Northwest.
Committed to attracting and retaining a diverse staff, the University of Washington will honor your experiences, perspectives and unique identity. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable and welcoming.
The University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran or disabled status, or genetic information.
To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 or firstname.lastname@example.org.
Applicants considered for this position will be required to disclose if they are the subject of any substantiated findings or current investigations related to sexual misconduct at their current employment and past employment. Disclosure is required under Washington state law.