Pharmaceutical Investigator - PI24-15289
NavitsPartners North Wales
Position: Pharmaceutical Investigator
Duration: 12+Months
Duration: 12+Months
Location: West Point, PA 19486
Job Description:
- 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.
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
Liveo ResearchNew Castle (DE), 41 mi from North Wales
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Liveo Research is a global manufacturer of rigid packaging solutions with five locations worldwide. Our pharmaceutical manufacturing plant in Delaware City, Delaware is looking for a Senior Quality Manager.
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NavitsPartnersWest Point (PA), 2 mi from North Wales
Position: Pharmaceutical Investigator
Duration: 12+Months
Location: West Point, PA 19486
Job Description:
• Leads and/or works as a team member on deviation investigations aimed to prevent deviation recurrence, including determining the root cause...
NavitsPartnersWest Point (PA), 2 mi from North Wales
Position: Pharmaceutical Investigator-Technical Writing
Location: West Point, PA
Duration: 12 months
Job Description:
• Primary responsibilities include day-to-day technical support to manufacturing operations, including resolution and reduction...