Lead Investigator, PET- Operations
AstraZeneca

Key Accountabilities:
• Ethical conduct and compliance
• Conduct in-depth investigations or deviations from standard conditions to establish root cause, corrective actions and any potential impact on the identity, safety, strength, quality and purity of drug substance.
• Authors reports that document the investigation of issues including definition, scope, product impact, root cause and corrective/preventive actions to address the root cause.
• Seeks and leverages the skills and technical expertise of internal and external resources to continuously improve the robustness, rigor and time to complete investigations.
• Initiates and leads investigation team to determine:
• Escalation and communication strategy so all stakeholders have appropriate information and may act in a timely manner
• Identify with stakeholders, containment actions appropriate to the situation
• Investigation strategy including a clear and actionable problem statement.
• Investigation tools that will be used
• Investigation action plan and timing.
• Root cause.
• Solution selection
• Identify CAPA owners and develop action plans and effectiveness checks.
• Utilizes the appropriate and approved investigations tools necessary to drive the team to root cause. This may include Level Zero, Practical Problem Solving or Six Sigma process robustness tool.
• As subject matter expert on problem solving techniques, the Lead Investigator coaches individuals in the different PS methodology.
• Prioritizes work to aid in timely decisions and completion of investigations. Escalates issues as appropriate.
• Conducts interviews to key personnel involved in deviations / non compliances to fully understand the nature of the failure, its scope and impact.
• Works within and across functions, sites and regions to ensure connectivity of investigations between functional areas and sites.
• Completes other duties as assigned.
• Effectively utilizes interpersonal skills to influence and hold others accountable for investigation actions without direct authority.

Essential:
• Bachelors degree required, preferably in Science, Engineering, or other related technical discipline.
• Five years in pharmaceutical Manufacturing and/or other similar regulated industry experience for Sr. role).
• Strong problem-solving abilities.
• Ability to direct and participate in cross-functional teams.
• Knowledge of GMP or regulated production environment
• Quality management and attention to details

Desirable:
• Advanced degree, Masters or higher
• Multiple site or function experience
• Lean and Six Sigma Certification
• Project management skills
• Planning and Organizing skills
• Excellent decision maker
• Interpersonal skills
• Computer skills

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.