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Quality Validation Specialist
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.
At MilliporeSigma, the Quality Validation Specialist is recognized as a strong quality presence and technical resource. The Specialist is responsible for developing, reviewing, and managing the execution of validation activities, and ensuring that the qualifications are consistent with the user’s/manufacturer’s requirements and quality standards.
- Interact cross-functionally with Manufacturing, Project Management, Process & Analytical Development, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, and Maintenance
- Oversee and perform computer systems validation activities for automated equipment and analytical equipment per requirements
- Provide input on improvement of testing documentation
- Support data integrity implementation and remediation for systems as needed. Participate in audits and continuous improvement efforts related to computer system validation and data integrity
- Utilize GDP in a GMP atmosphere while generating protocols and reviewing documents
- Review and generate closing reports for executed protocols
- Work through a Management of Change system to determine the impact of proposed changes to the qualification status of equipment, software, or facilities
- Identify and establish revalidation requirements
- Write and execute qualification packages, technical reports, and validation master plans
Who You Are:
- Bachelor’s Degree in Chemistry, Biochemistry, Biology, Computer Science or other Life Science field
- 2+ years of life science validation experience
- Working knowledge of current regulatory guidelines and standards
- Ability to apply and incorporate regulatory standards, rules, and guidance. (e.g. FDA, EU, ISO, ISPE, etc.)
- Comfortable in a fast-paced environment with the ability to adjust to changing priorities
- Detailed-oriented work standards
- Sound understanding of Quality Risk Management concepts
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