Lab Quality Assurance Specialist jobs in United States
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Optum · 5 months ago

Lab Quality Assurance Specialist

Optum is redefining health care with a focus on health equity, affordability, quality, and convenience. 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.

EducationHealth CareMedicalPharmaceutical
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H1B Sponsor Likelynote

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

Qualification

Quality Assurance ProgramsLaboratory Compliance StandardsMedical Technologist CertificationLaboratory ExperienceLean MethodologiesEffective CommunicationOrganizational SkillsTeam Collaboration

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

Benefits

Comprehensive benefits package
Incentive and recognition programs
Equity stock purchase
401k contribution

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.

H1B Sponsorship

Optum has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (648)
2024 (559)
2023 (620)
2022 (851)
2021 (593)
2020 (438)

Funding

Current Stage
Late Stage

Leadership Team

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Daniel Castillo
Chief Executive Officer, Optum Care Delivery
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J
Jay Green
Chief Financial Officer
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Company data provided by crunchbase