Quality Assurance Specialist 3 - Compliance and Audits

MilliporeSigma; Rockville (MD); On-site; USD 71,000 - 106,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Job summary

MilliporeSigma in Rockville, MD, seeks a Quality Specialist 3 to provide independent quality oversight in a GMP/GLP laboratory setting. You will ensure regulatory and client requirements are met through investigations, risk-based decisions, and continual improvement within a robust QMS.

Collaborative with operations, technical and client teams, this role enhances inspection readiness. The role requires a life sciences degree and 2+ years in QA audits or CAPA handling.

Qualifications

• Auditing experience in QA or regulatory environments.
• Root cause analysis and CAPA handling experience.
• Ability to interpret regulatory requirements and guide operations.

Responsibilities

• Lead or support client, internal, regulatory audits and inspections.
• Lead audit preparation, responses, and tracking of corrective actions.
• Drive inspection readiness and monitor audit commitments and CAPAs.
• Review and approve deviations, investigations, CAPAs, and risk assessments.
• Provide SME guidance on root cause analysis and quality investigations.
• Interpret regulatory requirements and advise operational teams.
• Review SOPs and GMP records, and support quality documentation.
• Facilitate risk assessments using HACCP and FMEA.
• Monitor quality metrics and drive continuous improvement initiatives.
• Support regulatory submissions, supplier qualification, and quality agreements as needed.

Skills

Auditing

CAPA management

Education

Bachelor's degree in life sciences

Job description

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your 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).

Key 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.

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.

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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!