Specialist, Supplier Quality
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:
Supplier Quality role related to the support of raw material, raw material suppliers and primary packaging material and supply chain re-qualifications (reassessments). Activities focus primarily on raw material specification creation, revisions, and inactivations, participation and supporting supplier audit execution as an auditor or lead auditor; routing of emails received in group mailbox to appropriate individual for resolution and obtaining supplier documentation. This position is an entry level role within a central supplier quality management team which supports production and supporting operations for multiple cell culture media manufacturing facilities. This role is predominantly a remote / home office position with a high degree of daily responsibility and accountability. The role does work on-site quarterly for support.
- Participate in or lead cross-functional teams for Change Management (Change Review Board and Raw Material Review Board), Quality Event management (deviation investigations, root cause analysis, CAPA plan development, and Supplier Corrective Actions), and Supplier Management (Supplier Review Board)
- Perform effectiveness check as applicable
- Management of specifications
- Perform Supplier, Material and Supply chain requalification (reassessments)
- Perform Supplier, Material and Supply chain inactivation and discontinuations
- Manage changes not requiring qualification
- Manage quality relationship through establishing quality agreement and supplier change notification agreements as applicable
- Participate in annual categorization activities
- Participate in department owned projects
- Assist with periodic internal/ customer audits to meet corporate and ISO requirements
- Perform supplier audits independently as a lead auditor or co-auditor
- Contribute to a safe working environment by following corporate and departmental safety regulations
Who You Are
Minimum Qualifications:
- Bachelor’s degree in any Life Science discipline
- 2+ years of quality assurance experience
OR
- Associate’s degree in any Life Science discipline
- 2+ years of quality assurance work
OR
- Associate’s degree in any Life Science discipline
- 1+ years of supplier quality experience
OR
- High School Diploma or GED
- 1+ years of quality assurance experience
- 1+ years of supplier quality experience
Preferred Qualifications:
- Thorough understanding of ISO 9001:2015 and Excipact GMP guidelines
- Self-starter who requires little to no direct supervision but also works very well as part of a large team
- Strong attention to detail, and follow written operating procedures
- A “team player” with excellent interpersonal skills
- Communicate effectively in both written and oral context
- Use effective problem-solving techniques, a thorough understanding root cause analysis
- Excellent organizational and time management skills
- 1+ years of experience in a Pharmaceutical, Biopharm, or other Healthcare industry with the demonstrable familiarity of cGMP’s, cGLP’s and/or related ISO requirements
- Experience using QMS software such as TrackWise or SAP
- Quality Auditor Certification or the ability to obtain certification
- Understanding of commercial Quality systems and their application in a manufacturing environment
- Good customer service skills and the ability to negotiate win-win outcomes
- Previous 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
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QA, Quality Assurance, Medical Lab, Change Management, Quality, Technology, Healthcare, Management