What are the responsibilities and job description for the Quality Assurance Specialist position at FEFA, LLC?
FEFA, LLC is seeking a detail-oriented and experienced Quality Assurance Specialist (QAS) to support clinical and research activities at the Naval Health Research Center in San Diego, CA. This onsite role is critical to ensuring compliance with regulatory standards, maintaining robust quality systems, and supporting the standardization of clinical trials documentation and Standard Operating Procedures (SOPs).
The ideal candidate will bring hands-on quality assurance experience, strong regulatory knowledge, and the ability to collaborate effectively with multidisciplinary teams in a research and laboratory environment.
Key Responsibilities
At FEFA, LLC, you will have the opportunity to support meaningful research initiatives in a highly regulated and mission-driven environment. We value professionalism, collaboration, and a commitment to quality and continuous improvement.
Equal Opportunity Employer
FEFA, LLC is an Equal Opportunity Employer and considers all qualified applicants without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other protected status.
The ideal candidate will bring hands-on quality assurance experience, strong regulatory knowledge, and the ability to collaborate effectively with multidisciplinary teams in a research and laboratory environment.
Key Responsibilities
- Develop, implement, and maintain Quality Management Systems (QMS) in compliance with applicable regulations and guidelines.
- Ensure adherence to CLIA, CLIP, CAP, and other relevant federal and state regulatory requirements.
- Conduct internal and external audits; prepare audit reports and track corrective and preventive actions (CAPAs).
- Analyze quality data, identify trends, and perform root cause analyses to support continuous improvement initiatives.
- Assist with the standardization of clinical trials documentation and SOPs, ensuring consistency and regulatory compliance.
- Review documentation and processes with a high level of accuracy and attention to detail.
- Prepare quality reports and present findings to management and stakeholders.
- Train and educate laboratory and research staff on quality standards, procedures, and regulatory requirements.
- Collaborate closely with researchers, laboratory personnel, auditors, and management to support quality objectives.
- Bachelor’s degree in a science-related field.
- One (1) or more years of quality assurance experience.
- Strong knowledge of CLIA/CLIP/CAP regulations and other applicable federal and state guidelines.
- Demonstrated experience developing and implementing Quality Management Systems.
- Proven auditing experience (internal and/or external).
- Strong analytical and problem-solving skills, including data analysis and root cause analysis.
- Excellent written and verbal communication skills.
- Exceptional attention to detail and documentation accuracy.
- Ability to work effectively with cross-functional teams.
- U.S. Citizenship with the ability to obtain and maintain a T3/Secret Clearance.
- Previous hands-on laboratory bench experience.
At FEFA, LLC, you will have the opportunity to support meaningful research initiatives in a highly regulated and mission-driven environment. We value professionalism, collaboration, and a commitment to quality and continuous improvement.
Equal Opportunity Employer
FEFA, LLC is an Equal Opportunity Employer and considers all qualified applicants without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other protected status.