QA Analyst (Southern WA and Portland, OR)

The Quality Analyst supports projects and activities as they relate to quality assurance, quality control, quality improvement, quality training. Performs other quality related duties as assigned by the Quality Manager.

• Coordinates and tracks results of internal proficiency testing program.
• Tracks timely reporting of internal and external proficiency testing (PT) results, maintaining accurate records of PT handling, reporting and follow up.
• Collects data and prepares local quality metrics reports as assigned.
• Reviews any outliers associated with quality metrics reports and assisting with development of corrective action and follow up processes.
• Performs quality audits and creating timely audit reports.
• Works with appropriate individuals in the laboratory to identify trends, solve problems, troubleshoot and modify processes to prevent recurrence of problems.
• Keeps Laboratory Director and Laboratory Manager informed of any significant issues affecting overall laboratory quality.
• Assists in annual review of the QA plan.
• Works with department supervisors to ensure new procedures are appropriately implemented and documented.
• Files for necessary licensure, certification and/or accreditation as appropriate for the laboratory’s test complexity.
• Performs administrative supports duties (e.g. maintaining records, generating and sending communications and reports, maintaining databases, entering data, answering phones, filing, etc).
• Monitoring and responding to other quality assurance issues as assigned or developed in the course of the other duties as described above.
• This position reports to the Quality Manager and receives a minimum amount of direct supervision.
• What to Expect reflects the essential functions of the position and excludes those that may be incidental to the performance of the job. In no way is it stated or implied that the principle functions are the only duties to be performed. Employees will be required to follow any other job-related instructions and to perform any other related duties as requested by their supervisor.

Education and Qualifications

• B.A./B.S. degree in medical technology, biology, or equivalent with 5-7+ years clinical laboratory experience to include: federal and state regulatory requirements, internal auditing, CAPA systems, writing SOPs, trending and analyzing data; experience with GMP and GTP desired.
• Ability to relate professionally with people, analytical abilities, compose letters/memorandum, coordinate events, motivate others, organization skills, research information, time management, train employees, written and verbal communications, supervisor skills.
• Speech clarity, utilization of fingers and hands, standing-remaining on one’s feet in an upright position, sitting-remaining in the normal seated position, handling-seizing, holding, grasping.
• Additional job duty (as assigned): (Hazardous Chemical Waste Management) Proper identification of known hazardous material in the work place.
• The knowledge of personal protection measures.
• The avoidance of accidents.
• The knowledge of hazardous waste characteristics, hazardous waste volume generation limits, accumulations limits, spill control measures, record keeping, proper handling and container management, labeling, container and storage inspection.
• Possible exposure to infection from disease-bearing specimens; regularly exposed to the risk of blood-borne diseases; must comply with applicable safety procedures.
• Far acuity-ability to see clearly at 20 feet or more; near acuity-ability to see clearly at 20 inches or less; depth perception-ability to judge distance and space relationships; color vision- ability to distinguish and identify different colors.

This position is will require both remote work and travelling.

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