Career Category
Quality
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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. 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 Assurance
What you will do
Let’s do this! Let’s change the world! The Sr. Associate Quality Assurance position supports Amgen’s Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Product manufacturing areas. Under general supervision, the role provides support and quality oversight of our Drug Product Manufacturing facility, ensuring the execution of our processes, procedures, and use of quality systems aligns with regulatory requirements.
Duties include but are not limited to:
Purposeful presence on the manufacturing floor (Form/Fill Grade 8 Gowning), 100% Manual Visual Inspection support, ASP/AQL performance, and QA Oversight Assessments
Electronic batch review
GMP Document (SOPs/FORMs) revision review/approval,
Review and approval of electronic Maintenance documentation Work Order/Job Plans.
Quality support and approval of minor deviations,
Electronic Batch Record (MES) documentation revisions and approvals
Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion.
Additionally:
Must be flexible with shift work (including weekends) and comfortable with gowning requirements to support 24/7 production in a Grade 8 (Clean Room) Drug Product filling facility.
Shifts may vary from 8hrs to 12hrs depending on rotation (Days, Swings, Graves)
Shift rotations will be required (Days, Swings, Graves) to support production schedule
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The quality assurance professional we seek is an employee with these qualifications.
Basic Qualifications:
High school/GED + 4 years of GMP experience OR
Associate’s + 2 years of GMP experience OR
Bachelor’s + 6 months of GMP experience OR
Master's
Preferred Qualifications:
Bachelor’s Degree in Biochemistry, Biology, Chemistry, or related science field
Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices
Experience managing projects through to completion meeting timelines.
Ability to evaluate documentation and operations according to company procedures.
Experience working with Quality Systems
Strong organizational skills and ability to manage multiple tasks at one time
Effective communication skills (both written and verbal)
Demonstrated ability to work as both a team player and independently
Display leadership attributes and drive improvement initiatives
Solid understanding and application of aseptic behaviors and principles
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll…