Senior Associate Quality Control - Days

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 Operational Excellence initiatives
• Demonstrated ability to navigate through ambiguity and provide a structured problem solving
• Demonstrated ability to deliver on schedule.

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 support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

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