Quality Specialist II
4 days ago
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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