Senior Associate Quality Control

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 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:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts

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