Quality Assurance Specialist

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, the Quality Assurance Specialist will work various internal departments to improve and execute processes in compliance with cGMP regulations in 21CFR 210, 211, Part 11 and in ICH Q7. Specific responsibilities include:

• Write, review, and approve Investigations, OOS (out-of-specification), OOT (out-of-trend), CAPAs and Change Controls.
• Participate in internal/external audits.
• Provide quality oversight and support for new product introductions and respond to quality-related customer questions as the primary quality point of contact.
• Write, review, and approve Operating Procedures, Manufacturing documents, Technical Transfer Protocols and other controlled documents under a Quality Managed System (QMS).
• Review batch records for completeness and accuracy based on GMP requirements to ensure acceptable product and process consistency.
• Release activities for cGMP product.
• Evaluate and authorize master packaging formulas, shipping records and manufacturing formulas.
• Interact with production and laboratory personnel regularly to ensure adequate communication and feedback for quality-related services to internal customers.
• Monitor product for quality related issues and collaborate on resolution.
• Lead process improvement initiatives and projects related to quality.
• Participate in Quality Assurance on the floor activities in manufacturing, packaging, and Quality control areas on a regular basis.

Who You Are:

Minimum Qualifications:

• Bachelor's Degree in Chemistry, Chemical Engineering, or other life science discipline.
• 5+ years of QA and QC experience.

OR

• Master's Degree in Chemistry, Chemical Engineering, or other life science discipline.
• 2+ years QA and QC experience.

Preferred Qualifications:

• Knowledge of ICHQ7 and API knowledge and/or experience.
• TrackWise and SAP experience.
• Proficiency in MS Word, MS Excel, MS PowerPoint.
• Ability to learn and operate other specific application software.
• Excellent communication (verbal & written) and customer interfacing skills.
• Experience writing technical documentation & reports.
• Ability to simultaneously manage multiple tasks/priorities.
• Good problem-solving, time management and negotiating skills.
• Capacity for independent work.
• Data analysis, presentation, and experimental design knowledge.

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