Quality Assurance Specialist 2

 

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, you will perform a variety of tasks within the Quality Assurance department including conducting audits and reviewing and approving regulated documentation. 

• Conduct trend analysis for deviations and review / approve applicable CAPA records. 
• Conduct laboratory inspections to include commissioning and/or internal audits. 
• Provide support for client regulatory submissions.
• Facilitate client audits, address client concerns and perform supplier audits. 
• Review and approve client and supplier quality agreements. 
• Review and approve standard operating procedures (SOPs), laboratory / batch records, GMP part numbers, and other quality records. 
• 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. 
• Review and approve validation files for assays and approve minor, major and critical impact deviations / OOS records. 

Who You Are:

 

Minimum Qualifications:

• Bachelor’s Degree in any discipline
• 2+ years' experience in Quality Assurance or Quality Control within a GxP environment. ​​​​​​​

Preferred Qualifications:

• 1+ years in a client facing role.
• Facilities and Supplier auditing experience.
• Open-minded, flexible and agile.
• Ensures deadlines are met.
• Works with cross-functional teams and builds networks within QA and Operations departments. 
• Collaborates with various teams to identify and implement improvements. 
• Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity). 
• Strong communication and interpersonal skills. 

 

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