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:  

At MilliporeSigma, the QA Product Release Specialist will perform a variety of functions according to established protocols to support quality review and release of purchased and produced goods prior to downstream use and delivery to customers.

Role responsibilities include the following: 

• Evaluate raw materials and final products to ensure compliance with import/export regulations, particularly those involving animal by-products (ABP).
• Oversee product assignment and release, ensuring raw materials and finished goods meet all analytical, packaging, and labeling specifications per regulatory and quality system requirements.
• Serve as a technical expert in risk assessment and mitigation for sourcing origin, GMOs, pathogenic agents, residual solvents, and heavy metals.
• Review vendor documentation such as certificates of origin and regulatory questionnaires to support product release and cross-functional requests.
• Support customer documentation needs, including the preparation of supply chain declarations, affidavits, and Certificates of Origin.
• Lead or contribute to product quality improvement projects aimed at enhancing product performance and customer satisfaction.
• Participate in internal audits and conduct training, serving as an auditor and trainer within the quality system.
• Act as QA subject matter expert during audits, including customer, regulatory, and registration audits, and perform batch reviews and usage decisions.

 Physical Attributes: 

• Environmental conditions: Varies depending on specific job responsibilities. 
• 80-100% office environment, 0-20% production, QC, and packaging on the floor engagement.

Who You Are

Minimum Qualifications: 

• Bachelor’s Degree in a Life Sciences discipline, or Chemistry, Pharmacy, Chemical or Process Engineering.
• 4+ years of experience in QA job function.

OR 

• Bachelor’s degree in any discipline.  
• 5+ years of experience in QA job function.

Preferred Qualifications: 

• Master’s degree in Chemistry, Biochemistry, Biology, Pharmacy, or Engineering.
• Knowledge of ISO 9001:2008 required, ISO 13485. 
• Knowledge of other regulatory requirements (i.e. USDA, FDA, EC, DEFRA, ICH, and EDQM).

• Knowledge of animal/human pathogens.
• Knowledge of transgenic plants and animals.
• Current fine chemical industry knowledge and/or experience.
• Knowledge of SAP – Resource Planning (ERP) Business tool related to COA generation and release of products.
• Root cause analysis experience especially with regard to SAP system investigations.

RSREMD

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