What are the responsibilities and job description for the Deviation Investigator position at Joulé?
Job Title: Deviation Investigator I
Location: West Point, PA
Hours/Schedule: Mon- Fri 8am-5pm
Type: Contract
Overview
Global pharma company looking for experienced quality professional, experienced with deviation investigations and management. Must bring a BS Degree and a minimum of 1 year's experience.
Responsibilities
Requirements
Education Minimum 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.
Ref: #558-Scientific
Location: West Point, PA
Hours/Schedule: Mon- Fri 8am-5pm
Type: Contract
Overview
Global pharma company looking for experienced quality professional, experienced with deviation investigations and management. Must bring a BS Degree and a minimum of 1 year's experience.
Responsibilities
- 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
Education Minimum 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
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.
Ref: #558-Scientific
