Manufacturing Compliance Specialist

MilliporeSigma; St. Louis (MO); On-site; USD 100,000 - 110,000; Full time

Job summary

An established industry player is seeking a Manufacturing Compliance Specialist to enhance quality operations at their St. Louis facility. This role is pivotal in managing quality records, supporting deviation investigations, and ensuring compliance with GMP principles. The ideal candidate will have a strong background in life sciences and experience within a Quality Management System. Join a diverse team that values innovation and is dedicated to improving lives through science and technology. Embrace the opportunity to work in a collaborative environment where your contributions will drive significant impact.

Qualifications

• 1+ years experience in a Quality Management System.
• Experience in an ISO or GMP environment.
• Strong documentation skills and attention to detail.

Responsibilities

• Manage quality records and deviations in compliance with GMP.
• Create and revise GMP documentation including SOPs.
• Support label room operations and ensure compliance.

Skills

Quality Management System (QMS)

Root Cause Analysis (RCA)

Corrective and Preventive Actions (CAPA)

SAP

Attention to Detail

Effective Communication

Time Management

Problem Solving

Education

Bachelor’s Degree in Chemistry

Bachelor’s Degree in Biochemistry

Bachelor’s Degree in Biology

Bachelor’s Degree in Life Sciences

Bachelor’s Degree in Engineering

Tools

Microsoft Office

Labelview

Loftware

Job description

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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

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Production and Manufacturing

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