Performs activities in support of dispositioning product while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Clients Standard Requirement Documents.Responsibilities * Represent Quality Assurance both internal and External, with Partners and Contract Manufacturers in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution * Train and/or mentor junior employees, including providing insights and education on processes and procedures. * Provides consultation or advice in alignment with QA policies; and develop an understanding of external partner and manufacturers site procedures. * Perform activities associated with reading product records for disposition (e.g. manufacturing record review, receipt, inspection, document review, shipping, etc). Activities may be on site at a partner or contract manufacturer or at a desk * Review, edit, or approve Clients controlled documents * Review and approval of investigations associated with raw materials, product, laboratory, facilities, and materials. * Continually evaluating Clients processes and procedures with an eye toward continuous improvementRequirements * Requires BS/BA in scientific discipline or related field and minimum 2-year relevant experience. Relevant experience may be substituted for education requirement. * Understanding of aseptic filling and/or packaging operations is preferred. * Good organizational skills and attention to detail * Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally and cross-organizationally. * Ability to handle multiple assignments and changing priorities. * Ability to learn and utilize computerized systems for daily performance of tasks * Ability to prioritize, manage multiple tasks, and meet deadlines * Ability to work a varied schedule including off shift and weekends. * Ability to travel up to 25% of time.