Quality Specialist 3 - Compliance and Audits
$70,800–$106,200 year
On-siteRockville, Maryland, United States
Job Summary
Lead or support client, internal, and regulatory audits and inspections while managing audit preparation, response, and tracking of outstanding compliance initiatives. Drive inspection readiness activities by monitoring quality metrics, identifying systemic issues, and leading continuous improvement initiatives. Review, approve, and lead deviations, investigations, CAPAs, effectiveness checks, change controls, and risk assessments, serving as a subject matter expert for root cause analysis. Interpret regulatory requirements and provide compliance guidance to operational teams, while reviewing SOPs, GMP records, and quality documentation. Facilitate risk assessments using tools such as HACCP and FMEA, and support client meetings, regulatory submissions, and supplier qualification activities. This role ensures compliance with regulatory requirements, internal procedures, and client expectations through investigation management and risk-based decision making within a GMP/GLP-regulated laboratory environment.
Required 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
Desired 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
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