What are the responsibilities and job description for the Quality Assurance Specialist - GMP position at Integrated Resources, Inc ( IRI )?
The Deviation Management Contractor will be responsible for deviation management activities in support of vaccine production at the West Point site. This engineer will be a member of the Technical Operations Deviation Management team within the ROTA End-to-End (E2E) technical operations unit. The primary responsibility of the individual will be investigation initiation and closure associated with vaccine technology/production in support of the operations taking place in the ROTA E2E. 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 is 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 manufacturing investigations and/or process improvement projects.
• Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to identify root cause and propose effective corrective and preventative actions (CAPAs).
• 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.
• Writes technical documents to support closure of deviations using the SAP system.
• Authors and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.
Quals--
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
• Experience authoring
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