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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.
At MilliporeSigma, as the Quality Specialist 2, you will perform a variety of tasks within the Quality Assurance department, including conducting audits and the reviewing/approving of various types of regulated documentation:
Hours: Sunday-Thursday 10:00am - 6:30pm
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
Review and approve minor, major and critical impact deviations / OOS records
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, client audits and supplier audits
Review and approve client and supplier quality agreements
Who You Are:
- Bachelor’s Degree in any discipline
- 1+ years in a quality role
Bachelor’s Degree in a scientific discipline (e.g., Biology, Biotechnology, Chemistry, etc.), OR a Bachelor’s Degree in a technical discipline (e.g., Computer Science, Information Technology, etc. )
2+ years' experience in Quality Assurance or related field within a GxP environment
- Strong work ethic and quality of work
- Experience meeting deadlines
- Works with cross-functional teams and builds networks within QA and Operations departments
- Open-minded and flexible
- Proficient knowledge and application of FDA (21 CFR Parts 11, 58, 210, 211 etc.) and EU regulations (cGMP, GLP, Data Integrity)
- Familiarity with International regulations (EMA, MHRA)
- 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