Manufacturing Compliance 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

MilliporeSigma in St. Louis, MO is seeking a Manufacturing Compliance Specialist for the Ewing Facility in St. Louis, MO. This Compliance Specialist will be responsible for supporting the Ewing operations through the management of quality records (deviations and CAPAs), managing the creation and updates of operating procedures, and assisting label issuance/management for production. This role will work collaboratively with QA, QC, Operations, Engineering, Validation, Process Development and Maintenance while adhering to GMP principles.

• Shift- Monday-Friday, 6am-2:30pm.
• Lead and support deviation investigations, including root cause analysis (RCA) and development of CAPA plans related to equipment, facility, and process issues.
• Manage change controls within a Quality Management System (QMS), ensuring timely and compliant implementation.
• Create and revise GMP documentation, including SOPs, packaging batch records, specifications, and forms.
• Maintain quality systems and ensure ongoing cGMP compliance across related processes.
• Generate and analyze trend reports for deviations, CAPAs, and change controls.
• Support label room operations, including label printing, execution of label accountabilities, and related GMP documentation.
• Utilize SAP for material consumption and label management, ensuring accuracy and compliance with production requirements.

Physical Attributes: 

• This position will reside in an office setting.
• Limited travel may be required for training and auditing purposes.

Who You Are:

Minimum Qualifications:  

• Bachelor’s Degree in Chemistry, Biochemistry, Biology, or other Life Sciences or Engineering discipline.
• 1+ years working within a QMS.
• 1+ years experience supporting an ISO or GMP environment.

Preferred Qualifications:

• 1+ years managing or participating in Deviation Creations, RCA, and CAPA implementation.
• Strong computer, document management, and attention to detail skills.
• Demonstrated ability to work within a cross-functional team.
• Effective oral and written communication skills.
• Effective, disciplined, and demonstrated documentation skills.
• Good time management/organizational skills.
• Strong computer skills including SAP and Microsoft Office.
• Strong math skills including metrics and conversions.
• Good grasp of RCA and CAPA.
• Ability to work well in a team setting.
• Excellent problem solving skills.
• Understanding of regulatory requirements such as ISO 13485 and 21 CFR Part 820.
• Become proficient and functional  in both Labelview (Custom labels) and Loftware (SAP).
• Update and approve labels for IVD and additional products.

RSREMD

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