Deviation Management Specialist - I (Assistant) - Katalyst Healthcares & Life Sciences
West Point, PA 19486
About the Job
Leads and/or works as a team member on deviation investigations aimed to prevent deviation recurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting product impact assessment.
Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
Supports and/or executes continuous improvement projects that increase compliance, simplify/ standardize, and/or gain efficiencies.
Manages timelines to ensure key compliance and customer due dates are met; escalates any potential misses and develops remediation plans when possible.
Assures consistent application of standardized work, engineering, and process tools.
Provides technical support to manufacturing shop floor for problems and issues.
Conducts and designs experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
Authors and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.
Requirements:
B.S. degree in Engineering or Sciences.
Minimum one (1) year post-bachelor's degree experience in a GMP (good manufacturing practices) manufacturing and/or technical support of GMP manufacturing operations (or M.S. degree with <1 year experience).
Demonstrated ability to drive results to hit assigned due dates.
Strong communication, collaboration skills and ability to drive accountability.
Strong problem-solving skillset.
Vaccine manufacturing.
Sterile processing.
Technical writing (e.g. investigations, technical protocols/reports).
Investigative tools (e.g. 5-whys, fishbone).
Experience authoring investigations for atypical events in a manufacturing environment.