Come join our bio-analytical laboratory client as they build their quality organization. Our client is at the forefront of applying stable isotope biomarkers in drug research and clinical trials, with a focus on rare diseases and gene therapy.
Our client is seeking a Quality Assurance Specialist to oversee QC, QA, and quality improvement for their laboratory operations across all divisions. Reporting to the VP of Biomarkers, this role will ensure compliance with local, state, and federal regulatory standards, including the Clinical Laboratory Improvement Amendments (CLIA) and GxP regulations (GLP, GMP).
Qualifications of the Quality Assurance Specialist:
Bachelor of Science degree in Chemistry, Biology, or equivalent discipline
5+ years in a GLP/GMP laboratory setting
Thorough understanding of appropriate laboratory regulations and standards
Excellent written and oral communication skills
Self-starter with a proactive approach; ability to act autonomously
Detail-oriented
Responsibilities of the Quality Assurance Specialist:
Lead virtual and on-site audits/inspections from customers, 3rd parties, and regulatory inspectors
Prepare timely responses to audit reports and lead follow-up inspections and corrective actions
Perform regular internal audits of GxP studies, processes, data, vendors, and facilities
Conduct final internal audits of GxP reports prior to client release
Review clinical results before sending to patients and physicians
Oversee management of all quality systems (e.g., Qualtrax, Greenlight Guru)
Train and provide feedback to staff on audit follow-up procedures
Review, write, and update SOPs
Occupational Code: 11-3051.01 (Quality Control Systems Managers)