Technical Services Department Specialist
3 days ago
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.
- 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.).
- Duties may require overtime work, including nights and weekends.
- Must be able to sit and stand for extended periods of time.
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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