Documentation Specialist
eTeam Inc
Documentation Specialist Track and review manufacturing batch records to ensure compliance with regulatory requirements. Follows up with Manufacturing Technicians to ensure corrections are completed in a timely manner. Maintain error tracking metrics to address and correct repeated violations of GDP. Coach shopfloor technicians on GDP as applicable Identify and escalate GDP issues that could affect the safety, efficacy and quality of drug substance. Review batch record structure and recommend simplifications to minimize errors as applicable. Ensure batch record review cycle time. Participate in deviation investigations and CAPA creation as applicable. Must be detail oriented and able to work quickly with a high degree of accuracy. Must possess sound interpersonal and information gathering skills, be able to work in a team environment and interact effectively with others. Years of Experience: 0 - 3 Years
Vacancy posted 3 days ago
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