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 approach, and a steadfast focus on safety, quality, and compliance.
The Quality Assurance Specialist is accountable for activities associated to Environmental and Critical Utilities Monitoring Program, including but not limited to; trend analysis, laboratory investigations and change control in a dynamic team environment.
- Provide technical expertise in environmental and utility monitoring
- Author technical documents (e.g. Environmental/Utilities Quarterly Reports)
- Perform trend analysis of generated environmental and utility monitoring QC data Lead laboratory investigations and audits
- Maintain training compliance and proficiency
- Follow safety guidelines, cGMPs and other applicable regulatory requirements
Master's degree and 3 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience
Bachelor's degree and 5 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience
Associate's degree and 10 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience
High school diploma / GED and 12 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience
- Previous experience in a regulated GMP environment
- Experience in the following areas: QC Microbiology methods, Environmental Monitoring, Endotoxin testing, Growth Promotion testing, Water sampling, Bioburden testing and Result Reporting
- Operation, maintenance, and troubleshooting experience with Environmental Monitoring equipment and instrumentation
- Background in audit settings
- Proven statistical knowledge, ability to trend data and apply corrective actions to interpretations of complex data sets
- Experience in technical writing skills within a highly regulated environment
- Previous investigational and problem-solving skills related to nonconforming events
- Exposure to Operational Excellence initiatives including Lean Manufacturing and 5S
- Exposure to regulatory agency inspectors (or participation in regulatory agency audits)
- 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.