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About the Role

Chenega Enterprise Solutions & Solutions, LLC is seeking a CLIA Compliance Analyst IV to support the Office of Laboratory Quality (OLQ). This role provides strategic guidance on infectious disease issues and manages various centers within the organization. Our company fosters a robust employee benefits program, quality leadership, teamwork, and recognition for performance.

Responsibilities

• Review and evaluate Method Validation (MV) plans, reports, verification studies, and supporting documentation for compliance with CLIA regulations, CDC quality standards, and internal policies.
• Review Standard Operating Procedures (SOPs), validation documentation, Instructions for Use (IFUs), and supporting records for consistency with approved laboratory practices.
• Provide clear, accurate, and actionable written feedback to laboratories on method validation submissions, identifying deficiencies and recommendations for compliance.
• Manage CLIA document control activities, including creation, revision, approval, version control, and archival.
• Review Document Change Requests (DCRs), maintain document control records, and guide laboratories on CLIA document control requirements.
• Conduct annual audits of approximately 25 CDC Atlanta ID laboratory branches for adherence to CLIA regulations and QMS.
• Support CDC ID laboratories through maintaining and improving internal consultation services.
• Assist with the creation of tools and resources for ID laboratory compliance and the Test Directory.
• Maintain and improve the process for submission, review, and approval of test method validation studies.
• Improve communication processes between OLSR/OLQ, ID laboratory staff, and ID laboratory leadership.
• Develop CLIA-related documents and processes, support external inspections, and develop CLIA-related training.
• Create tools and resources for compliance to quality standards and support laboratories with consultations.
• Conduct coordinated CLIA and quality audits, support external reviews, and work with ID laboratories on corrective actions.
• Collaborate with laboratory management to implement corrective actions and continuous improvement initiatives.
• Review data and evaluate for test specificity, precision, and reproducibility, documenting review process and approvals.
• Make recommendations for updating physical ID laboratory processes, system and infrastructure requirements, quality management guidelines, and protocols.
• Maintain the CDC ID Test Directory, initiate test order updates, and provide recommendations for process improvement.
• Identify potential compliance risks and develop mitigation strategies.
• Travel to CDC facilities for conducting annual laboratory audits.
• Perform other duties as assigned.

Requirements

• Master’s or Ph.D. degree in Microbiology, Life Sciences, chemical, physical, biological or clinical laboratory science.
• 7+ years of experience in a diagnostic laboratory or similar regulated environment performing or supervising high complexity microbiology with a minimum of 6 months in subspecialty of service.
• Experience in Method Validations and Verifications.
• Experience with Molecular biology techniques.
• Certified in Molecular Biology.
• Experience with Methods Applied to Research and Clinical Diagnosis.
• Knowledgeable of laboratory compliance issues.
• Ability to read, analyze and interpret general laboratory periodicals.
• Experience writing technical laboratory reports, laboratory procedure manuals, and business correspondence.
• Previous auditing experience preferred.
• At least 7+ years of experience in a compliance or regulatory role within a clinical laboratory or healthcare setting, with a strong understanding of CLIA regulations.
• ASCP, AMT, or AAB Board Certification preferred.
• Ability to understand and apply new regulations.
• Experience with or knowledge of Quality Assurance procedures.
• Must be attentive to detail and organized, especially related to documentation and record-keeping.
• Familiarity with CLIA regulations and standards.
• Ability and judgment to interact and communicate appropriately with other employees, clients, and management.
• Proven track record and experience in building and cultivating strong relationships.

Skills

• Method Validation
• Method Verification
• Molecular biology techniques
• Laboratory compliance
• Technical report writing
• Procedure manual writing
• Business correspondence
• Auditing
• Quality Assurance
• CLIA regulations
• Interpersonal communication
• Verbal communication
• Written communication
• Data organization
• Report generation

Location

• Remote
• Atlanta, GA

Work Type

• Remote
• Onsite (periodic meetings and assessments)

Experience Level

• 7+ years

Education Level

• Master's or Ph.D.

Salary/Compensations

• USD $110,000.00/Yr. Up to USD $120,000.00/Yr.

Benefits

• Robust employee benefits program
• Management engagement
• Quality leadership
• Atmosphere of teamwork
• Recognition for performance
• Promotion opportunities

About the Company

• Chenega Enterprise Solutions & Solutions, LLC is a Chenega Professional Services’ company.
• Our company offers employees the opportunity to join a team where there is a robust employee benefits program, management engagement, quality leadership, an atmosphere of teamwork, recognition for performance, and promotion opportunities.
• We actively strive to channel our highly engaged employee’s knowledge, critical thinking, innovative solutions for our clients.