Investigator/Senior Investigator - Newark, DE | Biospace
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Investigator/Senior Investigator

AstraZeneca Pharmaceuticals LP

Newark, DE
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Areas of Expertise Desired:

Job Description

Location: Newark,
United States
Job reference: R-014211

Posted date: Sep. 15, 2017

Investigator/Senior Investigator

The Investigator/Senior Investigator
in Newark, DE is responsible for performing investigations and driving each event to conclusion by working with others. The Senior 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.

Main Duties and Responsibilities

  • 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 tools.
    • Investigation action plan and timing.
    • Root cause.
    • Solution selection.
    • 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.
  • Trains, coaches, and mentors associates to build a pool of individuals capable of completing investigations to standard (primarily an accountability for a Senior Investigator).
  • Completes other duties as assigned.


Essential Requirements

  • Bachelor’s degree required, preferably in Science, Engineering, or other related technical discipline. Relevant work experience will be considered in lieu of a degree.
  • Experience in Pharmaceutical Manufacturing and/or other similar regulated industry.
  • 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.
Desirable Requirements
  • Advanced degree, Masters or higher
  • Multiple site or function experience

Please note we will be filling a total of 2 positions: Senior Investigator (Career Level D) and Investigator/Senior Investigator (Career Level C/Career Level D). Placements will be made based on the skills and experience of the selected candidates.

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.