Quality Assurance Manager

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.

With a strong reputation and consistent double-digit growth, our client is now under new leadership and poised to accelerate growth and expand into new segments. Their team is comprised of proven leaders with a history of building highly successful companies across industries.

Our client is seeking a Quality Assurance Specialist to oversee QC, QA, and quality improvement for their laboratory operations across all divisions. Reporting to their 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)