Quality Specialist 3 - Quality Systems

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

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Other perquisites

Sales/Performance bonuses

Job summary

MilliporeSigma in Rockville, MD, is seeking a Quality Specialist 3 to support Contract Testing Services. You will ensure compliance with cGMP, GLP, and regulatory requirements while performing quality tasks, reviewing documents, investigations, and audits.

Collaborate with QA and Operations, author and review controlled quality records, manage CAPAs, host audits, and support regulatory inspections to maintain readiness and drive continuous improvement.

Qualifications

• Bachelor's Degree and 4+ years in Quality Assurance within a GxP environment.
• Knowledge of 21 CFR 11, 58, 210 & 211, EU GMP, and related regulations.
• Strong communication and teamwork skills.

Responsibilities

• Author, review and approve SOPs, laboratory and batch records and other quality documents.
• Review and approve events/deviations, investigations and CAPAs.
• Lead root cause analysis using approved tools (e.g., Fishbone, GEMBA).
• Host change control committee meetings and approve change controls.
• Support regulatory inspections and maintain inspection readiness.
• Audit and inspection readiness and support continuous improvement.

Skills

Quality Assurance

Regulatory knowledge

Cross-functional collaboration

Documentation review

Education

Bachelor's Degree

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

The Quality Specialist 3 supports our Contract Testing Services by ensuring compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and applicable regulatory requirements. This role independently performs routine to moderately complex quality tasks. Responsible for executing quality systems activities, including document review, investigations, and audit support. Works collaboratively with various teams including QA and Operations to support compliance and maintain quality standards while developing proficiency in quality systems and regulatory requirements.

• Author, review and/or approve controlled quality documents, including SOPs, laboratory and batch records, and other quality records.
• Review and approve events/deviations, out-of-specification investigations, complaints, and other investigations of varying impact and criticality.
• Lead root cause analysis via use of approved tools (e.g., Fishbone, GEMBA).
• Own and/or review and approve CAPAs and conduct trend analysis to facilitate verification of CAPA effectiveness.
• Support customer discussions related to investigations and CAPAs.
• Host change control committee meetings, review and approve change controls.
• Assist with developing training material and provide training for review and approval of QMS records and other controlled quality documents.
• Review study-related documents (e.g., protocols, technical specifications, data, certificates of analysis).
• Host customer, internal and/or supplier audits in accordance with applicable cGMP/GLP requirements.
• Review and approve audit responses and applicable follow-up actions/CAPAs.
• Support regulatory inspections and maintain awareness of inspection readiness requirements.
• Support continuous improvement initiatives to enhance quality and compliance.
• Support maintenance of SOPs and adherence to global regulatory (e.g., FDA, EMA) and internal requirements.
• Ensure accuracy, completeness, and compliance of documentation.
• Audit and inspection readiness

Who You Are

Minimum Qualifications:

• Bachelor's Degree
• 4+ years' experience in Quality Assurance within a GxP environment.

Preferred Qualifications

• Practical knowledge of 21 CFR 11, 58, 210 & 211, EU GMP, MHRA GLP & GMP, OECD GLP, ICH Q7, ISO 9001, and other applicable regulations, standards, and guidelines.
• Excellent communication and interpersonal skills.
• Ensures quality of own work in an ethical manner.
• Open-minded, flexible and works with agility.
• Works with cross-functional teams and builds networks within QA and Operations departments.
• Collaborates with various teams to identify and implement improvements.
• Willing to embrace and implement change on a global scale.

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.

• health insurance
• paid time off (PTO)
• retirement contributions
• other perquisites
• Position may be eligible for sales or performance-based bonuses.

RSREMD

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!