Career Category
Operations
Job Description
Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Senior Associate Quality Control
What you will do
Let’s do this. Let’s change the world. In this vital role you will provide support for QC Centralized Raw Material Testing in the Wet Chemistry Laboratory at Amgen Rhode Island.
The Sr. Associate Quality Control (QC) position will provide support for QC Centralized Raw Material Testing in the Wet Chemistry Laboratory (Monday – Friday 8:00 am – 4:30 pm) at Amgen Rhode Island.
The Sr. Associate QC will be responsible for execution of routine tasks and testing including but not limited to time sensitive samples from Centralized Raw Material testing (compendial testing).
Responsibilities:
Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with safety guidelines, cGMP (Good Manufacturing Practices) practices and other applicable regulations
Generates complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks
Operates laboratory equipment and instrumentation
Performs routine raw material testing
Management of the Raw Material Testing Master Schedule
Performs review and approval of assays, documents and records
Review/Approval of results in LIMS
Interfaces with CTL and enter results in LIMS
Site SME for specialized testing (i.e. Auto-titration, Colorimeter, FTIR, and SOR)
Supports troubleshooting and problem solving
Alerts management of quality, compliance, supply and safety risks
Supports TRAs and deviations, as a technical SME
Support and drive Continuous Improvement initiatives
Instructor on several specialty tests
Document ownership for Raw Material testing procedures
Completes required assigned training to permit execution of required tasks
Performs additional duties as specified by management
Basic Qualifications :
Master’s degree OR
Bachelor’s degree and 6 months of Quality, Manufacturing, or Operations experience OR
Associate’s degree and 2 years of Quality, Manufacturing, or Operations experience OR
High school diploma / GED and 4 years of Quality, Manufacturing, or Operations experience
Preferred Qualifications:
Experience executing analytical /biological testing per Methods and/or Compendia
Experience with QC analytical systems and/or Quality systems
Excellent interpersonal, written and verbal communication skills with all levels within the organization
Ability to work in a team matrix environment and build relationships with partners
Experience leading teams or projects
Identify, manage, and champion innovative projects to advance productivity and enable LEAN principles across different functions
Experience in auditing and defending processes, procedures and decisions during regulatory inspections
Demonstrated innovative thinking and ability to transform work organizations
Strong technical writing skills within a highly regulated environment
Exposure to Operational Excellence initiatives
Demonstrated ability to navigate through ambiguity and provide a structured problem solving
Demonstrated ability to deliver on…