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Quality Assurance Specialist 3 - Compliance and Audits

Merck KGaARockville, MD· posted Aug 5, 2026
Quality

We are looking for a Quality Specialist 3 – Compliance and Audits to provide independent quality oversight within a GMP/GLP-regulated laboratory environment. Lead audits, ensure regulatory compliance, and support continuous improvement. Ideal for candidates with experience in quality assurance and compliance within life sciences.

requirements

Minimum Qualifications: • Bachelor's degree in a life science discipline. • 2+ years' experience in conducting internal audits, client audits, or Client quality agreements in a Quality Assurance role. • 2+ years' experience in leading and/or reviewing root cause analysis and CAPA for deviations in a Quality Assurance role Preferred Qualifications: • Experience in a GxP CRO/CDMO/CTO or multi-client environment. • Experience with inspection readiness programs and regulatory responses. • Experience analyzing compliance metrics and quality trends. • Working knowledge of FDA 21 CFR Parts 58, 210, 211, Part 11, EU GMP requirements, and ICH Q9/Q10. • Broad quality systems experience across multiple QA disciplines. • Experience in conducting supplier audits • Demonstrate proven track record of effective communication with internal stakeholders and external clients. • Strong analytical, communication, organizational, and problem-solving skills. • Demonstrated ability to work independently, influence stakeholders, and foster a culture of quality and compliance. Pay Range for this position: $70,800-106,200 annually The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here. RSREMD EMDRSR What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

skills Bork detected

GMPQuality Assurance
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