Quality Assurance Specialist I

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:

• Ensure that all aspects of product manufacture meet production, packaging, labeling, and test specifications in accordance with established quality systems
• Support the maintenance, development, and improvement of quality systems, such as auditing, training, and change control
• Make batch release determination and generate CoA and other specified batch documents.
• Perform review and release of raw materials and finished products in a timely manner
• Assure any lot deviations and Out of Specifications (OOS) are completed and closed
• Perform label approval, label generation, and review of daily QA paperwork to include charts, monitoring exhibits, and environmental records
• Review batch records prior to production
• Answer questions from internal and external customers
• Participate in and lead cross-functional deviation investigations, root cause analysis, and CAPA plan development, maintaining CAPA tracking and performing effectiveness check as applicable
• Assist in customer audits including opening/closing meetings, tours, document reviews and any follow-up activities as necessary
• Assist in periodic internal audits to meet corporate and ISO/EXCiPACT requirements
• Approve masterbatch records and batch records, assuring accuracy and completeness and resolve any discrepancies in documentation
• Contribute to a safe working environment by following corporate and departmental safety regulations
• Perform new hire and ISO/EXCiPACT training
• Maintain Site Quality filing systems

Who you are:

Minimum Qualifications:

• Bachelor’s Degree in Chemistry, Biology, or other Life Sciences discipline
• 1+ year direct Quality Assurance experience in a GMP environment
• 2+ years of experience in a Pharmaceutical, Biopharm, or other Healthcare environment

OR

• High School Diploma or GED
• 1+ year direct Quality Assurance experience in a GMP environment
• 4+ years of experience in a Pharmaceutical, Biopharm, or other Healthcare environment where they used cGMPs, cGLPs, ISO, and/or EXCIPACT requirements

Preferred Qualifications:

• Experience using QMS software such as TrackWise or SAP QN
• Quality Auditor Certification or the ability to obtain certification
• An understanding of commercial Quality systems and their application in a manufacturing environment
• Excellent customer service skills and the ability to negotiate win-win outcomes
• Experience as an auditor of supplier products and services

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