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Batch Record Review Specialist
2 months ago
Essential Qualifications:
- Extensive experience in evaluating and documenting completed Batch Records
- Skilled in Microsoft Office Suite (Word, Excel, Teams)
- Prior knowledge or experience in inventory oversight, tracking, and deviation management using Document Management Software (preferably SAP)
- Exceptional organizational abilities with meticulous attention to detail
- Understanding of Fermentation processes, compounding, and serial production
- Willingness to investigate and resolve issues by identifying discrepancies, verifying open deviations, and ensuring proper execution of batch records
Preferred Qualifications:
- Bachelor's Degree or relevant background in Bio Safety, Pharmaceuticals, Technical Writing, Training, Quality Assurance, Quality Control, Life Sciences, or Validation
- Experience in the pharmaceutical or manufacturing sector (or Bio production, GMP)
- Familiarity with change management and deviation management from a quality assurance perspective
Daily Responsibilities:
Insight Global is looking for a Documentation Specialist for a manufacturing facility. This role will focus on the assessment of finalized batch records submitted by the manufacturing team. The review process aims to identify documentation inaccuracies, calculation mistakes, deviations from production protocols, or any other exceptions. The evaluation and processing of manufacturing batch documents will necessitate access to various systems for inventory oversight, tracking, and deviation management.
