Quality Specialist 3 - Compliance and Audits

About the role

Quality Specialist 3 – GMP/GLP Compliance provides independent quality oversight within a GMP/GLP-regulated laboratory environment. This role ensures compliance with regulatory requirements, internal procedures, and client expectations through investigation management, risk-based decision making, audit support, inspection readiness, and continuous improvement. The position partners with operational, technical, and client stakeholders to maintain an effective and inspection-ready Quality Management System (QMS).

Responsibilities

• Lead or support client, internal, regulatory audits and inspections.
• Lead audit preparation, audit response, and tracking of outstanding compliance initiatives.
• Drive inspection readiness activities and track audit commitments, CAPAs, and compliance actions.
• Review, approve, and/or lead deviations, investigations, CAPAs, effectiveness checks, change controls, and risk assessments.
• Serve as a subject matter expert for root cause analysis (RCA) and quality investigations.
• Interpret regulatory requirements and provide compliance guidance to operational teams.
• Review and approve SOPs, GMP records, and other quality documentation.
• Facilitate risk assessments using tools such as HACCP and FMEA.
• Monitor quality metrics and trends, identify systemic issues, and lead continuous improvement initiatives.
• Support client meetings, regulatory submissions, supplier qualification activities, and client quality agreements as needed.

Requirements

• 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

Pay range for this position: $70,800–106,200 annually. 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

• Health insurance
• Paid time off (PTO)
• Retirement contributions
• Other perquisites

More information about benefits.

About Us

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!