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Clinical Laboratory EUA Compliance Specialist

Aerotek

01/05/2021

Posting ID: JP-001970386

Full Time
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Description:

The CLIA EUA Compliance Specialist, in conjunction with Verily cross functional teams (Quality, Regulatory, Compliance) and the CLIA Laboratory team (Laboratory Manager, Technical Supervisor, General Supervisors) and Research team will:

● 1. Coordinate the Laboratory Quality Control, Quality Assurance, and Technical Competency program focused on Covid 19 testing EUA related compliance.

● 2. Works with the Laboratory Manager and Technical Supervisor to ensure that all EUA specific Quality Control and Quality Assurance procedures are kept updated and are in compliance with CA State, CLIA and CAP guidelines.

● 3. Maintains and reviews the Quality Assurance / Quality Control records on a monthly basis to identify trends and suggests corrective actions if deemed necessary. Reports problems that require policy and/or procedural changes to Technical Supervisor, laboratory manager and Medical Director.

● 4. Responsible for the coordination of Verily EUA updates with Regulatory, Quality and Research teams.

● 5. On a limited basis, provides general supervision for the laboratory if requested.

● 6. Participates in the cross functional development and implementation of policies and procedures specific for C19 EUA’s. Ensures that procedures are appropriate and common for laboratories in which this practice is indicated.

● 7. Assists in the review, development, evaluation and writing of laboratory procedures, methods, and/or protocols.

● 8. Assists in evaluating, validating, implementing, and monitoring methods for assays considered or newly introduced in the laboratory under EUA approval.

● 9. Meets established deadlines for routine duties and special projects consistently.

● 10. Demonstrates advanced competency in areas of specialized testing and regulatory compliance, quality assurance, completion of laboratory based projects, and problem solving.

● 11. Review, writing, and editing of approved laboratory procedures and inputs into the development of new protocols, procedures, and processes for EUA compliance.

● 12. Demonstrates good time management in the performance of assigned tasks while working both productively and without the loss of accuracy.

● 13. Handles compliance and workflow for unsupervised sample collection under EUA authorization.

● 14. Demonstrates the ability and willingness to be flexible in meeting changing staff and shift assignments.

● 15. Provides for the accurate reporting of laboratory results to ensure continuity of patient care by demonstrating computer, communication, and documentation skills. Can perform basic LIS troubleshooting functions to ensure efficient operation of LIS.

● 16. Demonstrates a professional attitude and approach to all work activities, to all personnel of the department and organization, and to our customer base.

● 17. Works well with other team members to achieve success. Honest, fair and inspires trust as well as respect for others.

● 18. Demonstrates a commitment to personal career growth in the field by maintaining annual continuing education to improve leadership effectiveness and technical expertise.

● 19. Adheres to laboratory policies and procedures, Verily attendance and tardiness policies, and demonstration of mutual respect for all laboratory personnel.

● 20. Demonstrates a positive, open-minded, 'can-do' attitude. Represents a team perspective and a willingness to solve problems. Offers on-going constructive comments and open communication to maintain peak operational workflow, safety, and quality.

● 21. Provides support for special projects or assignments as needed. Performs other administrative duties within the laboratory section as necessary and/or requested.

Skills:

Compliance, EUA, CLS, clinical laboratory scientist, QC

Additional Skills & Qualifications:

Responsibilities:

● The Clinical Laboratory EUA Compliance Specialist will be on site on a full time basis.

● The Clinical Laboratory EUA Compliance Specialist will be responsible for working with the Technical and General Supervisors, or designees, to ensure compliance and ongoing monitoring of meeting both vendor and company EUA compliance requirements.

● The Clinical Laboratory EUA Compliance Specialist will participate with the CLIA lab leadership for implementation of the Quality Performance plan, with guidance from the Laboratory Director.

● The Clinical Laboratory EUA Compliance Specialist will work closely with Quality and Regulatory Departments to ensure compliance with company FDA approved EUA’s, especially with regard to MDR’s.

● The Clinical Laboratory EUA Compliance Specialist may be requested to work with Business Development and Strategy to expand revenue opportunities and menu offerings for additional EUA approval use cases.

Minimum Qualifications:

● CA State licensing as Clinical Laboratory Scientist

● 5-10 years experience in a CLIA certified clinical laboratory

● Experience as a Compliance or QC CLS, General Supervisor or Technical Supervisor

● Strong communication skills, both written and verbal

● A proven track record of quality

Preferred Qualifications:

● Microbiology, Molecular or Virology specialty

● Molecular automation experience, including pooling

● Previous experience in a clinical laboratory compliance or regulatory role

Experience Level:

Expert Level

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Contact Information

Recruiter: Laura Lopeman

Phone: (650) 825-2917

Email: llopeman@aerotek.com

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