AstraZeneca Pharmaceuticals LP Lead Investigator in West Chester, Ohio
The Lead Investigator is responsible for performing investigations and driving each event to conclusion by working with others. The Lead Investigator ensures the investigation outcome, root cause analysis, and resulting solutions (CAPAs) are completed in a timely, effective, and compliant manner. The speed and rigor demonstrated by the Lead Investigator will drive a culture that prevents unplanned deviations through a robust and proactive investigation process. Manage deviations from identification to resolution. Technical Writing responsibilities and reporting.
Conducts organized investigations with a well-defined scope, strategy, and timeline documenting status and progress of the investigation and CAPAs.
Authors reports that document the investigation of issues including definition, scope, product impact, root cause, and corrective actions to prevent the recurrence of the issue.
Seeks and leverages the skills and technical expertise of internal and external resources to improve the speed and rigor of investigations.
Collaborates with an investigation team to determine:
Communication strategy so all stakeholders have appropriate information.
Investigation strategy including a clear and actionable problem statement.
Investigation action plan and timing.
CAPA action plan and effectiveness checks.
Utilizes the appropriate and approved investigation tools necessary to drive the team to root cause.
Prioritizes work to aid in timely decisions and completion of investigations. Escalates issues as appropriate.
Works within and across functions, sites, and regions to ensure connectivity of investigations between functional areas and sites.
Education, Qualifications, Skills and Experience:
Bachelor’s degree required, preferably in Science, Engineering, or other related technical discipline. Relevant work experience will be considered in lieu of a degree.
Three to five years in Pharmaceutical Manufacturing and/or other similar regulated industry (> 5 years of experience for Sr. role).
Understanding of Lean tools (problem solving sessions).
Ability to quickly assess and assimilate technical data and conduct a thorough investigation; ability to present findings, conclusions, and complex information in a clear, concise, and logical manner.
Excellent written, verbal, and presentation skills.
Thorough understanding of the internal core business process including relevant cGMP and regulatory. Adept at identifying and understanding the critical factors in order to generate appropriate solutions.
Attention to detail and data integrity is essential. Ability to monitor activities to accomplish stated objectives in an effective manner.
Must be able to work in a fast-paced and rapidly changing environment. Ability to prioritize work activities to meet customer needs and deadlines.
Must be proficient with Microsoft Office Suite and have a working knowledge, or the ability to learn, computer systems such as TrackWise, SAP, LIMS, and Electronic Batch Record Systems.
Must be able to take accountability with excellent follow up and follow through; owns issues through the full cycle investigation process.