Quality Assurance 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

Support GMP production by performing batch record issuance, review, correction, release, and retention as well as periodic assessments for production lab compliance. Support the site’s maintenance, development and improvement of Quality Systems, such as training, CAPA, deviation, change control, and documentation control. Ensure that all aspects of GMP product release meet analytical, production, packaging, and labeling specifications in accordance with established quality systems. Supports the site’s compliance activities through regulatory recordkeeping and reporting. Responsibilities and tasks include:

• Ensure product and process consistency through GMP batch record review, deviation reporting, and investigation of anomalies.
• Support and maintain GMP documentation, including procedures, protocols, and specifications.
• Contribute to site compliance by managing quality systems (HR4You, Trackwise, Mango) and reporting site metrics.
• Train and support QA personnel, maintain safety standards, and uphold regulatory and quality policy awareness.
• Collaborate cross-functionally to resolve issues, implement improvements, and drive continuous improvement initiatives.
• Oversee system entries, deliver quality training, and identify process enhancement opportunities.
• Maintain accurate records, meet performance goals, and perform additional duties as assigned.

Who You Are 

Minimum Qualifications:

• Bachelor’s degree in chemistry, Biology, or other Life Science discipline.
• 2+ years of GMP experience working in a FDA regulated environment.  
• 2+ years of work experience in the chemical, specialty chemical, and/or pharmaceutical industry. 

Preferred Qualifications:

• Experience in high volume and high data environment.
• Knowledge of chemistry with an emphasis on analytical or organic chemistry.
• Knowledge of cGMP, cGLP, cGDP, and ISO 9001 procedures.
• Knowledge of ISO and GMP quality standards.
• Proficient in Microsoft Office Suite.

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