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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Senior Associate Quality Control

Live

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.

• Perform routine and non-routine evaluations and data review
• Perform testing and data analysis for compendia, non-compendia methods, and routine laboratory procedures
• Perform testing methods including HPLC, GC and GC-MS and other compendial methods such as UV, pH, appearance
• 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.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Master's Degree OR
• Bachelor's Degree and 2 years of Quality experience OR
• Associate's degree and 6 years of Quality experience OR
• High school diploma/GED and 8 years of Quality experience

Preferred Qualifications:

• Strong knowledge and understanding of GMP pharmaceutical production and associated testing methods experience.
• 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 carrying out compendia test methods for raw materials (ACS, EP, FCC, USP)
• Operation, maintenance, and troubleshooting experience with lab equipment and instrumentation
• Demonstrated proficiency with electronic systems (LIMS, Trackwise, etc.)
• Ability to interpret scientific literature (ICH)
• Exposure to Operational Excellence initiatives including Lean Manufacturing and 5S
• Exposure to regulatory agency inspectors (or participation in regulatory agency audits)
• Experience in investigations, change control, validation, audits, QC processes
• Strong communication skills (technical writing and oral), facilitation and presentation skills
• Knowledge and experience with Quality Control testing and GMP laboratory operations for common pharmacopeia testing methods, cell-based assays and protein analysis testing methods and associated equipment.
• Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality.

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and increase your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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