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Quality Assurance Specialist 2

2 months ago

Rockville, United States MilliporeSigma Full time

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:
At MilliporeSigma, as the Quality Assurance Specialist 2, you will perform a variety of tasks within the Quality Assurance department including conducting audits and review / approval of various types of regulated documentation.
- 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.
- **Shift: Monday-Friday 10:00am to 6:30pm
**Who You Are:
**Minimum Qualifications**:

- 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 in a science field or a GxP environment.

**Preferred Qualifications**:

- Basic knowledge of FDA regulations (21 CFR Parts 11, 58, 210, 211 etc.)
- Familiarity with International regulations (EMA, MHRA).
- Strong communication and interpersonal skills.
- Acts ethically and ensures quality of own work and that of others.
- Open-minded, flexibility and works with agility.
- Ensures deadlines are met by taking initiative.
- Works with cross-functional teams and builds networks within QA and Operations departments. Collaborates with various teams to identify and implement improvements.

**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