Vacancy caducado!
DEVIATION SPECIALIST WEST POINT, PA Onsite. Project Description:
- Providing on-the-floor support of operational and technical issues.
- Collaborating with the shop floor to provide immediate responses to deviations and potential deviations.
- Conducting real time investigations with the goal of fully understanding root cause and product impact within five days of event discovery.
- Performing deviation investigations and customer complaints aimed to prevent deviation/complaint re-occurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment.
- Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.
- Completing projects to improve the performance of our processes, including projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and continuous improvement projects that seek to improve yield, reduce cost, or lower our processing cycle times.
- Supporting team safety, environmental and compliance objectives.
- Managing investigation and complaint timelines to ensure key compliance and customer due dates are met, escalating any potential misses and develop remediation plans when possible.
- Collaborating effectively with the area Coaches, Operators/Mechanics, support groups (Maintenance, Automation, Technology, Quality, and Planning).
- Actively using and championing the use of Lean Six Sigma (LSS) and Client's Production System tools, both in problem solving and day-to-day operational activities .
- B.S./M.S. degree in appropriate engineering/scientific field.
- Minimum of 0-3 years post-bachelor's degree experience in a cGMP environment (e.g., Production, Development, Process Engineering, Technical Services, or related field) in pharmaceutical/ biotech industry.
- Previous experience in writing investigations for atypical events in a manufacturing environment.
- Familiar with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities.
- Demonstrated ability to work both independently and as a part of a cross-functional team.
- Excellent written and verbal communication skills.