Technical Services Department Specialist

3 days ago


Bloomington, Indiana, United States Baxter Pharmaceutical Solutions LLC. Full time
About the Role

The Technical Services Department Specialist plays a vital role in supporting the Technical Transfer, Process Validation, and Manufacturing Technical Services departments at Baxter Pharmaceutical Solutions LLC. This position is responsible for providing day-to-day administrative support, processing workflows for documents used during or in support of filling operations, and ensuring the smooth execution of manufacturing processes.

Key Responsibilities
  • Coordinate the cross-functional review, approval, and release of various new and revised Technical Services documents to support the Fill Complex.
  • Review, edit, and process TS documents, including Master Batch Records (MBRs), Protocols, Summaries, Risk Assessments, and TS Studies.
  • Generate document change control for Fill Complex.
  • Manage workflows in the Electronic Data Management System (EDMS) for both electronic and manual routing of documents.
  • Submit documents to clients for review/approval and work with clients to properly identify and incorporate any client-requested changes into the documents.
  • Manage document issuance and document delivery to meet scheduled manufacturing demand.
  • Copy, filing, printing/organizing, and other various department-related tasks.
  • Lead process improvement initiatives and meet deliverable deadlines.
  • Provide documents and assistance during internal and external audits.
  • Own and track CAPAs (Corrective & Preventive Action), as assigned.
  • Act as Process Owner for Documentum and Trackwise and provide training to other staff members in viewing, reviewing, approving, and processing documents.
Requirements
  • High School diploma or GED required.
  • 3+ years in an administrative environment.
  • Experience using various Electronic Data Management Systems (or related) preferred.
  • Microsoft Office Suite - advanced proficiency.
  • Knowledge and ability to use enterprise software (Documentum, Trackwise, Veeva, SAP).
  • Attention to detail (proofread, formatting, etc.).
Physical/Safety Requirements
  • Duties may require overtime work, including nights and weekends.
  • Must be able to sit and stand for extended periods of time.
What We Offer

Baxter Pharmaceutical Solutions LLC is proud to offer a comprehensive benefits package, including medical and dental coverage, flexible spending accounts, life and AD&D insurance, supplemental life insurance, short and long-term disability insurance, 401(k) retirement savings plan with company match, time off program, adoption reimbursement program, education assistance program, employee assistance program, community and volunteer service program, and more.



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