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.
As part of the Amgen's Manufacturing Operations organization, our Amgen Woburn Manufacturing (AWM) site manufactures oncolytic virus based end-to-end drug substance and drug products for the global market. As such we continuously strive to be a leader in detailed execution to ensure we deliver our medicines to every patient, every time. Operational Excellence is at the core of how we do what we do with a continuous improvement attitude, and an unyielding focus on safety, quality, and compliance.
Quality System's Specialist is responsible for day to day quality system oversight in a dynamic plant that produces both clinical and commercial drug substance and drug product at the Amgen Woburn facility. Cross functional quality responsibilities will include investigation support, CAPA management, and ownership of individual Quality Processes as the Business Process Owner. Supporting and project managing investigations for major and critical non-conformance (Class 2 and 3) events associated with Amgen manufactured products and to develop strong corrective and preventative actions to prevent re-occurrence. Ensuring the investigations and prescribed corrective and preventative actions are complete and robust to assure the safety and quality of Amgen products.
- Review and Approval of Investigations and CAPAs
- Support investigation teams to identify meaningful root causes and robust corrective and preventative actions by effectively utilizing advanced root cause analysis tools (Causal Factor Analysis or Kepner-Tregoe).
- Document thorough and well written investigation reports
- Provide updates to senior leadership including metrics at Management Review
- Lead site Management Review meetings
- Drive Operational Improvement projects
- Support program alignment with Global Amgen Quality Systems
- Support regulatory inspections by directly interfacing with inspectors to present non-conformances and corrective and preventative actions.
Master's degree and 3 years of Quality and/or Operations experience
Bachelor's degree and 5 years of Quality and/or Operations experience
Associate's degree and 10 years of Quality and/or Operations experience
High school diploma/GED and 12 years of Quality and/or Operations experience
- Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies
- Experience in investigations and CAPAs processes
- System knowledge and training in Trackwise
- Experience in managing multiple, competing priorities in a fast-paced environment
- Direct bulk drug substance and drug product experience
- 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
- Established Leadership capabilities
- Passion for Operational Excellence
- Financial acumen
- Communications skills, both oral and written, including executive presentation skills
- Interpersonal and facilitation skills necessary to forge consensus among competing client interests while ensuring objectives are met
- Ability to tactfully negotiate and positively influence peers and executive leadership
- Analytical skills to identify potential improvement opportunities
- Knowledge of industry trends (e.g., regulatory and compliance, technology, human performance programs, sustainability, etc.)
We understand that to successfully sustain and grow as a global enterprise and deliver for patients — we must ensure a diverse and inclusive work environment.
Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission – to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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.