Job Description

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.

Your Role:

At MilliporeSigma, as the Quality Assurance Specialist 3, you will perform a variety of tasks within the Quality Assurance department including investigations, deviations, and regulated documentation.

• Act as the Subject Matter Expert and train new employees in the Investigative Process and techniques.
• Analyze and evaluate information captured through investigations, communicate findings and recommendations.
• Review and approve OOS, trend, critical-impact deviations and lower impact events.
• Conduct trend analysis for deviations and review / approve applicable CAPA records.
• Author, review and approve standard operating procedures (SOPs), quality policy documents, and laboratory / batch records.
• Review and approve assay validation documentation and new GxP service documentation.
• Review and approve manufacturing documentation including: technical specification, production records, environmental monitoring trends.
• Negotiate terms of quality agreements for suppliers and customers.
• Train Quality Specialists and/or Operations teams on quality topics.
• Review and approve change control (GCC) records.
• Assist supervisors and managers with team workload assignments.
• Participate on interview panel for prospective QA team candidates.
• Lead and/or participate in customer and/or supplier meetings to discuss audit observations, investigations, or negotiate quality agreements.
• Conduct commission inspections for current, new or renovated laboratories.
• Act as Quality SME during regulatory inspections and customer audits for areas of expertise.
• 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 systems.

Who You Are:

Minimum Qualifications:

• Bachelor\'s degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, etc.).
• 4+ years\' experience in a Quality role GxP environment.
• 1+ years\' experience on investigative process and techniques in a Quality role.

Preferred Qualifications:

• Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity).
• Experience with reviewing and approving CAPA records, Effectiveness checks and GCC records.
• Excellent communication and interpersonal skills.
• Open-minded, flexible and works with agility.

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

Job Requisition ID: 267896

Location: Rockville

Career Level: D - Professional (4-9 years)

Working time model: full-time

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

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