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Documentation Specialist
3 months ago
Must Haves:
- Strong experience reviewing and reporting completed Batch Records
- Proficient in Microsoft Office (Word, Excel, Teams),
- Previous experience or knowledge of inventory control, tacking, and deviation management in a Document Management Software (Preferably SAP)
- Strong organizational skills with a high attention to detail
- Knowledge of Fermentation, compounding, serial production
- Appetite to investigate and problem solve by identifying errors omissions, checking for open deviations, and ensuring batch records were executed properly
Plusses:
- Bachelors Degree or background in Bio Safety, Pharma, Technical Writing, Training, Quality Assurance, Quality Control, Life Sciences, or Validation
- Previous Pharma/manufacturing experience (Or Bio production, GMP)
- Knowledge or previous experience with change management and deviation management from a quality perspective
Day to Day:
Insight Global is seeking a Document Specialist for a manufacturing site in De Soto, KS. This person will be primarily responsible for the review of executed (completes) batch records received from Manufacturing team. Review is to discover documentation errors, calculation errors, deviations from manufacturing instructions, or any other kind of exception. Processing/review of manufacturing batch documents will also require access to and actions within various systems for inventory control, tracking, and deviation management.
