Sr. QA Associate Specialist

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 Sr. Quality Assurance Associate provides compliance oversight across the MilliporeSigma Quality Management System (QMS) in collaboration with site personnel. As a Sr. QA Associate, you are responsible for the coordination and maintenance of Quality Systems (i.e., Document Control, Record Control, Training Program Maintenance, Deviation/CAPA, Complaints, Change Control) and processes to ensure internal and external compliance and the promotion of quality practices that meet or exceed required guidelines and regulatory requirements. Responsibilities include maintenance and continuous improvement of the overall Quality Program.

• Support and improve ISO 9001 and ISO 13485 quality systems, ensuring alignment with regulatory standards.
• Manage documentation control activities, including authoring, reviewing, and approving controlled documents within the electronic documentation system.
• Coordinate training management, including tracking metrics and administering the electronic training platform.
• Assist with quality investigations, including customer complaints, root cause analysis, and effectiveness checks.
• Conduct or support internal audits, acting as lead auditor when required.
• Ensure compliance with CAPAs, deviations, complaints, and change controls, contributing to department KPI achievement.
• Deliver and support quality system training relevant to job functions and compliance needs.
• Collaborate cross-functionally to execute and continuously improve quality-related processes and meet department goals.

Physical Attributes: 

• Environmental conditions: Varies depending on specific job responsibilities.
• 70-100% Office Environment, 10-30% On-the-floor QA activities/observation.
• Physical requirements: Give site tours of facilities including use of stairs.

Who You Are

Minimum Qualifications:

• Bachelors Degree in Chemistry, Biochemistry, Biology, or other Life Science discipline.
• 2 +years’ experience in QA function.

Preferred Qualifications:

• Knowledge of ISO 9001 and ISO 13485 and regulatory compliance issues (i.e., FDA, USDA, ICH, EDQM, IVDR) related to biologic derived materials, and prior experience working in a controlled/regulated environment.
• Current fine chemical industry knowledge &/or experience.

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!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!