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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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, under minimal supervision, you will be responsible for activities including Raw Material testing using sophisticated instrumentation, such as HPLC, GC and GC-MS, sample/data management and equipment/instrumentation operation and maintenance in a highly dynamic, team environment.
Responsibilities include:
Perform testing methods including HPLC, GC and GC-MS
Perform testing and data analysis for compendia, non-compendia methods, and routine laboratory procedures
Perform routine and non-routine evaluations and data review
Generate accurate and concise laboratory documentation using electronic systems and notebooks
Operate and maintain specialized laboratory equipment and instrumentation
Participate in laboratory investigations, inspections and audits
Stay in sync with safety guidelines, cGMPs and other applicable regulatory requirements
Support training of new staff as applicable
Ensure facilities, equipment, materials, organization, processes, procedures and products align with cGMP practices and other applicable regulations
Perform review and approval of procedures, assays, documents and records, including but not limited to deviation records and CAPAs
Alert management of quality, compliance, supply and safety risks
Completes required assigned training to permit completion of required tasks
Support Continual Improvement initiatives, programs and projects.
Ensure that changes that could potentially impact product quality are assessed according to procedures.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is detail oriented with these qualifications.
Basic Qualifications:
High school diploma/GED and 4 years of Quality experience OR
Associate's degree and 2 years of Quality experience OR
Bachelor's Degree and 6 months of Quality experience OR
Master's Degree
Preferred Qualifications:
Experience in HPLC, GC, ICP-MS and/ or GC-MS
Demonstrated laboratory technique with pipetting small volumes accurately
Professional work experience in a fast-paced, flexible GxP laboratory
Experience executing analytical 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 communication skills (technical writing and oral), facilitation and presentation skills
Exposure to…