GMP Operations Document Specialist

At MilliporeSigma, as the GMP Document Specialist at our Cherokee site / 3300 S. Second Ave, St Louis, you will be expected to manage document updates within GMP Operations.

This position requires an understanding of GMP guidelines, exceptional organizational and detail-oriented skills, and the ability to work effectively in a fast-paced environment.

The GMP Document Specialist position is a key role within our GMP Operations Systems & Support team, which supports Manufacturing through various functions including training, 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.

Own and execute GMP document updates in response to CAPAs, audits, change controls, etc. 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 Who You Are : Minimum Qualification : Bachelor’s Degree in a scientific or technical discipline (e.

g., Engineering, Chemistry, Biochemistry, Biology, etc.) 1.5 + years’ experience in a pharmaceutical GMP operations environment (Manufacturing, Quality, MSAT) OR High school diploma or GED 3+ years’ experience in a pharmaceutical GMP operations environment (Manufacturing, Quality, MSAT) Preferred Qualifications : 3+ years experience in a pharmaceutical GMP operations environment (Manufacturing, Quality, MSAT) including strong knowledge of GMP API manufacturingExperience revising and reviewing GMP documentsIntermediate experience using MS Word, MS Excel, MS PowerPoint and ability to learn and operate using other specific application software 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