* 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 improvement
* 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.