New 
Deviation Management Specialist
 Spectraforce Technologies | |
remote work
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 United States, Pennsylvania, West Point | |
 Mar 13, 2025 | |
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Deviation Management Specialist
12 months West Point, PA 19486 Qualifications: Education Minimum Requirements: * B.S. degree in Engineering or Sciences. Required Experience and Skills: * 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. Preferred Experience and Skills: * 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 Responsibilities: The primary responsibility of the individual will be investigation initiation and closure associated with manufacturing deviations and development of actions in response to these deviations (i.e. identifying root cause, recommending corrective/preventative actions, assessing product impact, and summarizing investigations in writing). Support will be focused on the Deviation Management process including operations support, equipment troubleshooting, implementation of process/equipment actions, and other related duties. This position will require development of technical expertise of process and product knowledge. This position is a site-based assignment and requires the employee to work at the site M-F. Two days of remote work per week may be available, work permitting, but is not guaranteed. Off-shift or weekend coverage may be required based on business unit needs and specific assignments. Responsibilities include: * 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. | |