Are you passionate about making a huge impact as an Investigator in a company that follows science and turns ideas into life-changing medicines? If so, then this position is for you!
In Operations, we have a big ambition - to deliver more medicines to patients, quicker and more affordably. Backed by the investment, leadership, and a clear plan to get there, we bring personal dedication and out-of-the-box thinking.
The AstraZeneca Newark Supply Site in Newark, DE, was established in 1971 and currently employs approximately 260 people. Over the course of these years, Newark has undergone many product portfolio changes since it first began as Stuart Pharmaceuticals through today as the designated AZ North America Packaging Center of Excellence and a Flexible Formulation site for global supply of complex products. The site provides a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca's priorities. It's important to us that you bring your full self to work every day. To help maintain your best self, here's a sneak peek into some of the things this site provides for you: on-site fitness center access, lunch & learns, sustainable office working environment, team, site and family activities, life-long learning, diversity & inclusion, tuition reimbursement, and dining center.
The Investigator / Senior Investigator is responsible for performing investigations and driving each event to a conclusion by working with others. The Investigator / Senior Investigator ensures the investigation outcome, root cause analysis, and resulting solutions (CAPAs) are completed in a timely, effective, and compliant manner.
This role will be hired at either an Investigator or Senior Investigator level depending on the experience and capabilities of the successful candidate.
What you'll do:
- 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.
- Bachelor's degree required, preferably in Science, Engineering, or other related technical discipline. Relevant work experience will be considered in lieu of a degree.
- 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.
- 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.
At AstraZeneca, we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth, and development.So, what's next
Are you already imagining yourself joining our team? Good, because we can't wait to hear from you!Find out more on Social Media:
- Facebook https://www.facebook.com/astrazenecacareers/
- Instagram https://www.instagram.com/astrazeneca/?hl=en
- About Operations https://www.youtube.com/watch?v=gak5Ham8oUw
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 authorization and employment eligibility verification requirements.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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