Quality Assurance Specialist Jobs

The Department of Laboratory Medicine serves as a regional resource for clinical laboratory services required for patient care, research, and educational programs in laboratory medicine. The department now employs 1400 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.

The Department of Laboratory Medicine and Pathology department has an outstanding opportunity for a QUALITY ASSURANCE SPECIALIST (FULL-TIME, DAY-SHIFT)

RESPONSIBILITIES:
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 datat 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
Document Control

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.

REQUIREMENTS:

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