Quality Specialist II

3 weeks ago


Alpharetta GA, United States Fulgent Genetics Full time
Job Details

Job Title: Quality Specialist II

Job Location: CSI Site - Alpharetta, GA

Job Category: QA - Quality Control

Description:

Fulgent Genetics, a leading provider of genomic testing and diagnostics, is seeking a Quality Specialist II to join our team. As a Quality Specialist II, you will play a critical role in ensuring the quality and compliance of our laboratory operations.

Key Responsibilities:

  • Review and update controlled documents, including laboratory SOPs and regulatory guidelines, to ensure compliance with CAP/CLIA standards.
  • Provide support in the compilation and organization of quality system and regulatory compliance data, including proficiency testing and assay validation.
  • Participate in audit preparation, interim inspections, and client-initiated audits.
  • Lead investigations into quality failures and non-conforming practices, identifying root causes and implementing corrective actions.
  • Review and respond to supplier questionnaires.
  • Assist in maintaining compliance for staff training, personnel files, and quality control processes.

Requirements:

  • Bachelor's degree in biology, chemistry, or related science.
  • 3-5 years of experience in a clinical pathology laboratory setting, with 2 years of quality experience.
  • Strong knowledge of state/local regulations, CAP/CLIA, OSHA, and FDA/ISO standards.

Additional Skills:

  • Detail-oriented with exceptional verbal and writing skills.
  • Proficient in Microsoft Office and spreadsheet compilation.
  • Highly organized and able to work independently with minimal supervision.

Work Environment:

Fulgent Genetics is an Equal Employment Opportunity Employer. The work environment is a general office setting with routine presence at the lab and other sites. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.



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