Deviation Investigator - DI00102

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