Quality Specialist 1

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Merck Group’s MilliporeSigma is hiring a Quality Assurance Specialist 1 for a full‑time onsite role in Rockville, MD. You’ll audit and review/approve SOPs, laboratory and batch records, study files, deviations, validation files, and conduct laboratory inspections. The most important qualifications are a bachelor’s degree in a science or technical field and at least 6 months of GMP/GLP experience, plus a strong eye for detail, the ability to meet deadlines, and comfort working with cross‑functional QA and Operations teams. Preferred: batch record review, basic FDA knowledge (21 CFR Parts 11, 58, 210, 211), familiarity with EMA/MHRA, and strong communication. No sponsorship; salary range $28-$43/hr; benefits apply.

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 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

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:

• Batch record review
• 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

Pay Range for this position - $28/hr - $43/hr

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety 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 a team that is dedicated to Sparking Discovery and Elevating Humanity!