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Investigator/Sr. Investigator - Newark, DE - Global Operations

Plats Newark, Delaware, USA Jobb-id R-065318 Datum inlagd 11/07/2019

At AstraZeneca we turn ideas into life-changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As an Investigator/Sr. Investigator in Newark, Delaware, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast-paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

Global Operations is fundamental to our purpose of delivering life-changing medicines to patients, touching every aspect of our business and providing a platform for everything that we do. We harness the specialist talents of 13,000 people around the world – 20% of our global workforce. With 30 production facilities in 18 countries, we’re focused on supplying our medicines with care, quality, and efficiency, reducing the time from lab to patient. Keen to bridge the gap between science and patients? Turn research into reality? And forge a global career that’s full of possibilities, as part of a world-class team? Come and thrive in our vibrant, energizing, connected and supportive culture and make a real difference to patients. Hear from our Senior Leaders about why they know AstraZeneca is a great place to work. https://lnkd.in/g8APibK

The Investigator / Senior Investigator is responsible for performing investigations and driving each event to a 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 Investigator / Senior Investigator will drive a culture that prevents unplanned deviations through a robust and proactive investigation process.

This role will be hired at either an Investigator or Senior. Investigator level depending on the experience and capabilities of the successful candidate.

Responsibilities:

Investigator / Senior Investigator

  • Conducts organized investigations with a well-defined scope, strategy, and timeline documenting the 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.
  • Completes other duties as assigned.
  • Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role.  Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time.   Report potential issues of non-compliance.
  • Ensures compliance with AZ Corporate Policies and Directives, site Standard Operating Procedures, regulatory requirements, and industry best practice (cGMPs).
  • Maintains a safe work environment and performs work in accordance with site Environment, Health, and Safety (SHE) policies, and procedures.
  • Immediately report potentially unsafe conditions to management.

Senior Investigator

  • Assume the role of Business Process Owner for the Deviation and CAPA Management process, including, but not limited to:
    • Monitoring and reporting on the health of the process including establishment and monitoring of appropriate Key Performance Indicators
    • Identifying and implementing continuous improvement initiatives
    • Developing and maintaining training materials for the process
  • Trains, coaches, and mentors associates to build a pool of individuals capable of completing investigations to standard.

Qualifications:

Education:

  • Bachelor’s degree required, preferably in Science, Engineering, or other related technical discipline. Relevant work experience will be considered in lieu of a degree.

Required:

  • 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.
  • Must be able to take accountability with excellent follow up and follow-through; owns issues through the full cycle investigation process.

Preferred:

  • Advanced degree, Masters or higher.
  • Multiple site or function experience.
  • Experience in Pharmaceutical Manufacturing and/or other similar regulated industry.
  • Computer system experience such as TrackWise, SAP, LIMS, and Electronic Batch Record Systems is preferred.

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 embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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