Senior Quality Assurance Specialist

3 weeks ago

Wilmington, Delaware, United States Tempus Full time
Quality Assurance Specialist Job Description

At Tempus, we are seeking a highly organized and systematic Quality Assurance Specialist to join our QA team. The ideal candidate will have a strong background in quality management systems and experience working in a clinical laboratory regulated by CAP/CLIA.

Key Responsibilities:
  • Support the Clinical Laboratory to ensure CAP/CLIA/FDA regulatory compliance in all aspects of laboratory operations.
  • Maintain CLIA certification, CAP accreditation, and State licensure for the clinical laboratory as required.
  • Lead, coordinate, and support various QA activities such as maintenance of training plans and training records, record retention for lab documents, and administration of multiple MediaLab Modules.
  • Author and review SOPs/policies, verification/validation plans, and reports.
  • Conduct laboratory walkthroughs and CAP self-inspections for the clinical laboratory, lead inspection readiness efforts, and host inspections as needed.
  • Track proficiency testing orders, participation, and performance.
  • Identify trends and provide metrics to drive root cause analysis and corrective actions to prevent the recurrence of quality issues.
  • Responsible for processing and managing issues/incidents, ensuring compliance to FDA 21 CFR 820, ISO 13485, CAP/CLIA, and other applicable quality system regulations and standards.
  • Participate in process improvements to the quality management system framework by identifying areas for improvement, simplification, and standardization.

Requirements:
  • Bachelor's degree required.
  • Minimum of 4+ years of related knowledge and experience.
  • Highly organized and systematic, superb attention to detail, and ability to complete tasks with a high degree of accuracy.
  • Strong interpersonal skills in the areas of written and verbal communication.
  • Self-motivated, organized, able to prioritize and organize time effectively.
  • Experience working with individuals to perform root cause investigations and to implement effective corrective actions.
  • Previous experience in a clinical lab regulated by CAP/CLIA is highly desirable. Experience in the FDA regulated industry - medical devices or IVDs is a plus.

Equal Opportunity Employer:
Tempus is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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