Quality Deviation Specialist from Joulé
West Point, PA 19486
About the Job
Job Title: Quality Deviation Specialist
Location: West Point, PA
Hours/Schedule: Mon- Fri 8am- 5pm
Type: Contract
Responsibilities
Requirements
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
Location: West Point, PA
Hours/Schedule: Mon- Fri 8am- 5pm
Type: Contract
Responsibilities
- 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.
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
- Experience authoring
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.