What are the responsibilities and job description for the GMP Operations Document Specialist position at MilliporeSigma?
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 3300 South Ewing location in St. Louis.
Minimum Qualification:
Preferred Qualifications
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
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 3300 South Ewing location in St. Louis.
- 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
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
- 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
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
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