Amgen Specialist Quality Investigations in West Greenwich, Rhode Island
Responsible for execution of the Nonconformance, Corrective and Preventative Action Quality System at ARI. Duties include: coaching and leading of peers in functional areas and Quality Operations in execution of investigations of varying complexity; facilitation of cross functional teams (internal and external to the Rhode Island site) with the goal of improving investigation execution; communication of Quality System status to Sr. Leadership in multiple forums; maintaining the metric reporting for site performance.
Partnering with Quality Control, Manufacturing and other support functions to ensure a robust NC/CAPA process.
Support regulatory inspections by directly interfacing with inspectors to present NC/CAPA process overviews as well as individual investigations.
Preparing defense strategies in support of regulatory inspections and internal audits.
Providing timely and comprehensive process and investigation status updates to senior management.
Creating and presenting investigation summaries for Senior Management review
Identifying and coordinating an investigation team to include all Amgen key stakeholders and subject matter experts necessary for a complete investigation.
Developing and managing the implementation of investigation plans for nonconformances.
Leading investigation teams to identify actionable root causes and robust corrective and preventative actions by effectively utilizing advanced root cause analysis tools (Causal Factor Analysis, Fault Tree Analysis, Kepner-Tregoe, etc.).
Doctorate degree OR
Master's degree and 3 years of Quality experience OR
Bachelor's degree and 5 years of Quality experience OR
Associate's degree and 10 years of Quality experience OR
High school diploma / GED and 12 years of Quality experience
Scientific degree in Life Sciences or Physical Sciences OR Applied Engineering or Manufacturing Technologies
Experience leading cross-functional/site investigation teams in complex deviations including determination of potential product impact, root cause, and corrective and preventative actions.
Experience in managing multiple, competing priorities in a fast paced environment with minimal supervision
Demonstrated leadership traits
Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff.
Ability to solve complex problems and make scientific risk based decisions.
Experience presenting to and interacting with representatives of regulatory agencies.
Trackwise database experience
Direct bulk manufacturing experience
Aseptic processing practical experience
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.