Quality Assurance Specialist 2 Jobs

Work Your Magic with us!

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:

At MilliporeSigma, as the Quality Assurance Specialist 2, youwill perform a variety of tasks within the Quality Assurance department including conducting audits and reviewing and approving regulated documentation.

• Facilitate client audits, address client concerns, and perform supplier audits.
• Conduct trend analysis for deviations and review / approve applicable CAPA records.
• Review and approve validation files for assays and approve minor, major and critical impact deviations / OOS records.
• Review and approve standard operating procedures (SOPs), laboratory / batch records, GMP part numbers, and other quality records.
• Conduct laboratory inspections to include commissioning and/or internal audits.
• Review and approve client and supplier quality agreements.
• Provide support for client regulatory submissions.
• Review and approve study files against regulatory and internal requirements to include protocols, technical specifications, raw data, final reports, cell banking production records, and certificates of analysis.

Who You Are:

Minimum Qualifications:

• Bachelor's Degree in any discipline
• 2+ years' experience in Quality Assurance within a GxP environment

Preferred Qualifications:

• Strong communication and interpersonal skills.
• Ensures deadlines are met.
• Open-minded, flexible and agile.
• 1+ years in a client facing role.
• Collaborates with various teams to identify and implement improvements.
• Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity).
• Works with cross-functional teams and builds networks within QA and Operations departments.
• Bachelor's Degree in a scientific discipline (e.g., Chemistry, Biology, Microbiology, etc.).

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it 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 our diverse team!

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html