Job Description

Title: Deviation Investigator Duration: 12 months Location : West Point, PA Qualifications: Education Requirements: B.S. or B.A. in Engineering, Sciences, or related discipline. 2-4 yrs experience (combination of co-op/Real world acceptable). Required Experience and Skills: Strong Technical Writing Skills, highly developed communication, Leadership and teamwork skills, Ability to manage projects/work to schedule/deadlines. Preferred Experience and Skills: Experience in biologics, vaccine, or bulk sterile manufacturing facilities, Change Control experience, Deviation Management Investigation. Responsibilities: Authors, supports, updates, and/or leads documentation updates such as SOPs, batch records, change control documents, technical protocols, validation documents and other GMP documentation Supports deviations, including assessment of product impact and determination of root cause and corrective/preventative actions, assists in writing of investigations as well as quality incidents. Supports equipment, and facility projects for various Sterile Supply Departments at the West Point site. Supports continuous improvement projects that increase compliance, reduce cost, and/or simplify/standardize the process. Examines complex issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve the root cause. Designs, conducts, and/or reviews and approves experimental protocols as needed. Provides on-the-floor support of complex operational and technical (process/equipment) issues. Completes and/or leads projects to improve the performance of our Company processes, including investigation and execution of Corrective/Preventative Actions (CAPAs); projects aimed at improving Right-First-Time performance or preventing/reducing deviations; and projects that seek to improve efficiency, reduce cost, or increase compliance. Supports team safety, environmental, and compliance objectives. Manages project timelines to ensure key compliance and customer due dates are met; escalates any potential delays and develop remediation plans when possible. Partners effectively with Operations, Quality, Planning, project teams, and external vendors. Notes: * This role will require Deviation Management work. Needs GREAT communication (written/spoken) skills. Deviation report includes gathering evidence, interviews with groups- needs to have comfort with investigations, asking questions (not afraid), gathering evidence. Good at technical writing  

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