Specialist Quality Assurance
Job ID: R-93379
Location: West Greenwich, RI, US 02817
Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that these molecules become medicines. Many of the technologies we're employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping oncology patients.
Responsible for proving quality oversight functions related to the manufacture of Bulk Drug Substance at Amgen Rhode Island.
- Manage the life cycle for Quality Control (QC) equipment, as system owner. Interact routinely with end customers and vendors, ensuring reliable QC equipment support in a fast-paced environment.
- Manage the procurement of new QC equipment. Work autonomously to lead cross-functional stakeholders to identify end-user requirements, establish validation requirements and Change Control strategy.
- Lead departmental capital funding projects. Lead and support Governance requirements to secure funding. Responsible to implement projects on time and on budget.
- Responsible for Quality and/or Validation Assessments for Change Controls.
- Supports inspection readiness activities across Quality Control, and site audits and inspections.
Master's degree and 3 years of Quality or Operations experience
Bachelor's degree and 5 years of Quality or Operations experience
Associate's degree and 10 years of Quality or Operations experience
High school diploma / GED and 12 years of Quality or Operations experience
- Previous experience in Quality Systems (Investigations, Corrective Actions/Preventative Actions - CAPAs, Effectiveness Verification - EVs, Change Controls)
- Validation experience (Lab equipment, computer related systems)
- Project management
- Proficiency in Excel, Word, and PowerPoint
- Strong interpersonal skills
- Excellent written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff
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.
We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.
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.
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.