Quality Assurance Specialist 2

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:

As a Quality Assurance Specialist 2 at MilliporeSigma’s Norwood, OH site, you will play a vital role in ensuring alignment with the ISO 9001:2015 Quality Management System (QMS) standard and Life Science Divisional Quality System requirements. This position requires keen attention to detail, thoroughness, and strong communication skills as you manage the electronic Quality Records system to ensure timely processing and completion of records.

Key Responsibilities:

• Assist in the investigation and resolution of customer complaints by collaborating with customers, Product Managers, Account Managers, Technical Services, and Customer Services
• Serve as Project Leader for Good Distribution Practice (GDP) implementation in the Distribution Center Warehouse
• Act as the Site Lead User for the TrackWise/VEEVA electronic quality record system, ensuring all records are entered and processed within defined due dates
• Coordinate external audits and assist in conducting internal QMS audits
• Ensure successful completion of critical investigations and lead in-depth analyses of out-of-specification (OOS) results, CAPA, complaints, deviations, change controls, and root cause analyses (RCA)
• Provide QA support for distribution quality issues and initiatives
• Collaborate with the QA team to write, review, and approve Operating Procedures, Work Instructions, and Forms
• Monitor the production floor, QC labs, and DC warehouses for quality-related issues, taking prompt action to resolve them
• Lead or participate in process improvement initiatives to enhance quality practices and systems.

Who You Are:

Minimum Qualifications:

• Bachelor’s Degree in Chemistry, Biology, or other Life Science Discipline
• 3+ years of experience in a GMP, GDP, or ISO 9001 environment

Preferred Qualifications:

• GMP, GDP, or ISO 9001 Lead Auditor certification
• 1+ years of customer-facing experience
• Familiarity with TrackWise, VEEVA, and SAP systems
• Project Management experience and GMP/GDP implementation
• Strong communication skills across all organizational levels
• Proficient report writing skills and knowledge of GDP/GMP methods and processes
• Ability to manage multiple projects and tasks simultaneously
• Strong technical expertise, problem-solving skills, and leadership capabilities
• Ability to identify necessary information and conduct research effectively

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