Lab Quality Assurance Specialist, Mid-Level

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Job Summary:

Optum is redefining health care with a focus on health equity and quality. The Laboratory Quality Assurance Specialist is responsible for ensuring accuracy, reliability, and regulatory compliance within laboratory processes, conducting audits, developing action plans, and implementing comprehensive quality assurance programs across the organization.

Responsibilities:

• Implement and maintain quality assurance and quality control programs to ensure compliance with regulatory standards, including the College of American Pathologists (CAP) and Clinical Laboratory Improvement Act (CLIA), Washington Department of Health (DOH), and other applicable guidelines

• Conduct audits and assessments of laboratory processes, procedures, and documentation to identify areas for improvement and ensure adherence to quality standards across the organization

• Conduct site visits to various laboratory locations for audits, assessments, and quality assurance evaluations

• Develop and revise standard operating procedures (SOPs) to enhance efficiency, accuracy, and compliance with regulatory requirements

• Perform quality control testing and monitor the performance of laboratory instruments and equipment

• Collaborate with laboratory personnel to provide guidance on quality assurance protocols, ensuring understanding and adherence to established procedures

• Investigate and resolve quality-related issues, including non-conformities and deviations, and implement corrective and preventive actions

• Develop and deliver training programs to educate laboratory staff on quality assurance principles, practices, and procedures

• Collaborate in the preparation of comprehensive QA reports for the clinic, utilizing a range of laboratory and clinic information systems and software

• Provide support during operational changes, ensuring smooth transitions and effective adaptation

• Ensure timely and accurate documentation of annual competency assessments for personnel, in accordance with the requirements set forth by CAP, CLIA, and DOH. Offer individual performance feedback to Laboratory leadership as needed

• Stay updated on industry trends, advancements, and changes in regulatory requirements, and implement necessary updates to ensure continuous improvement

• Maintain accurate and up-to-date records of quality assurance activities, including audit findings, corrective actions, and quality control results

• Participate in proficiency testing and external quality assessment programs to ensure the accuracy and reliability of laboratory results

• Serve as a bench technologist, as necessary, supporting laboratory operations

Qualifications:

Required:

• Bachelor's degree or higher in a chemical, physical, biological, or clinical laboratory science, or medical technology

• Certification as a Medical Technologist (MT) or Medical Laboratory Scientist (MLS) by a nationally recognized agency (e.g., ASCP, AMT, AAB)

• 4+ years of laboratory training or experience, including 1+ years in a high complexity testing laboratory

Preferred:

• A background in lean methodologies, project management, or process improvement

• Proven capability of managing multiple tasks and prioritizing responsibilities effectively

• Proven solid organizational skills are essential for maintaining comprehensive QA programs, managing documentation, and ensuring timely completion of annual competency assessments

• Proven professionalism, integrity, and the ability to work collaboratively in a team environment are crucial for fostering a positive work culture and building solid working relationships with colleagues, physicians, and patients

Company:

Optum is a healthcare company that provides pharmacy services, health care operations, and population health management. It is a sub-organization of UnitedHealth Group. Founded in 2011, the company is headquartered in Eden Prairie, Minnesota, USA, with a team of 10001+ employees. The company is currently Late Stage. Optum has a track record of offering H1B sponsorships.