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Quality Assurance Specialist 1

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 Specialist 1, 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:

- 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 deviation records and validation files for systems and assays
- Conduct laboratory inspections
- **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. ) 6+ months work experience in GMP/GLP environment

**Preferred Qualifications**:

- 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
- Basic knowledge of FDA regulations (21 CFR Parts 11, 58, 210, 211 etc.)
- Familiarity with International regulations (EMA, MHRA) Strong verbal and written communication 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