Documentation Specialist

Title: Documentation Specialist ILocation: Pearl River, NYDuration: 6 Months+ Possible ExtensionShift- 1stPay Rate : $30 - $35/hr on w2Work Schedule - Monday thru Friday; 7:30am thru 4:00pmMust Have:Experience; CAPA, Batch review, technical writing, knowing how use documentation systems, locate errors and change action requirements.Quality system, Tech writers, CAPA, ERP, experience.Documenting systems or similar for tech writerPharma/ bio tech is requiredPreferred skills:Manufacturing GDP experience DeviationsDescription: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 applicableIdentify 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.Years of Experience: 0 - 3 Years