GMP Operations Document 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:

The GMP Document Specialist position is a key role within our GMP Operations Systems & Support team, which supports Manufacturing through various functions including training, quality compliance, equipment and facility cleaning, and raw material coordination. Expectations of the GMP Operations System & Support team are to ensure compliance and readiness within our GMP Manufacturing teams, ultimately enabling high manufacturing success.   This will be at our Cherokee location. 

• Own and execute GMP document updates in response to CAPAs, audits, change controls, etc. 
• Conduct independent evaluations and propose changes to stakeholders concerning the robustness, ease of use, clarity, and other aspects of operational documents, including MMFs, MPFs, forms, and templates. 
• Revise and review GMP documents including but not limited to SOPs, forms, MMFs, MPFs, and training documents Utilize document management system to coordinate document workflows, review and approve documents, etc. 
• Work effectively cross-functionally by interacting daily with colleagues across the site including Manufacturing, OSS, Quality, and MSAT, to identify and implement areas for document improvements 
• Logbook management for manufacturing and packaging including issuance, tracking, retirement, and archival Periodic review management including issuing tasks, tracking updates, and reporting metrics, for Manufacturing, OSS, and MSAT 
• Coordinate with training team to ensure documents are created, maintained, and obsolesced in the eDMS and LMS as required 
• Ability to manage and prioritize high volume of document tasks 
• Identify and execute process improvement projects  

Who You Are: 

Minimum Qualification: 

• Bachelor’s Degree in a scientific or technical discipline (e.g., Engineering, Chemistry, Biochemistry, Biology, etc.) 

• 2+ years’ experience in a pharmaceutical GMP operations environment (Manufacturing, Quality, MSAT) 
• Intermediate experience using MS Word, MS Excel, MS PowerPoint and ability to learn and operate using other specific application software 

OR 

• High school diploma or GED 

• 3+ years’ experience in a pharmaceutical GMP operations environment (Manufacturing, Quality, MSAT)   
• Intermediate experience using MS Word, MS Excel, MS PowerPoint and ability to learn and operate using other specific application software 

Preferred Qualifications:

• 4+ years experience in a pharmaceutical GMP operations environment (Manufacturing, Quality, MSAT) including strong knowledge of GMP API manufacturing
• Experience revising and reviewing  GMP documents

• Strong interpersonal and communication skills and the ability to work effectively within a team environment 
• Ability to gain consensus and drive positive change 

• Detailed oriented with a future oriented mindset  

• Possess a high degree of motivation and are a self-starter with initiative to Think Outside the Box 

• Proficiency with ManGo and Trackwise systems 

• Demonstrated process improvement experience 

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