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 material or final products (repack or manufactured) to determine 

acceptability to meet import/export requirements that are derived from animal by-product 
(ABP). 

• Ensure that all aspects of routine product assignment and release for raw materials and finished 

goods meet analytical, packaging, and labeling specifications in accordance with established 
quality systems and regulatory/industry requirements. 

• Technical/consultative expert for risk assessment evaluations & implementation of mitigation 

strategies related to; pathogenic agents, sourcing origin, genetically modified organisms, 
residual solvents, and/or heavy metals within the supply chain.  

• Review vendor documentation (certificate of origin, customer or regulatory questionnaires, etc.) as part of product release 

or as requested by Project Management, Technical Services, Customers, Sales, Marketing and/or 
regulatory agencies. 

• Assist with customer related documents, including supply chain declaration/affidavits and 

Certificate of Origin creation. 

• Perform product specific projects to improve product quality performance, product quality 

information and/or improve customer satisfaction as requested by Project Management, Technical 
Service, Sales, and/or Marketing. 

• Act as an auditor of the Internal Auditing Program as required.
• Conduct Training (individual, group).
• Batch review and usage decision.
• Participation in customer audits, regulatory audits, and registration audits as a subject matter expert of QA product release processes and practices. 

 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.  
• 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