Career Category

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 – Critical Reagents Group

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will under general supervision, be responsible for one or more of the following activities in Quality Control including Critical Reagent qualification design, data analysis, expiry extension, and release into commercial operations. The Senior Associate Quality Control will be assigned to the first shift but may support a non-standard shift organization that may include weekends.

SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

• Write and develop technical documents including Standard Operating Procedures (SOP), qualification protocols (PTC), qualification results reports (RPT), Certificate of Analysis (COA), and Data Summary Spreadsheets (DSS) for Critical Reagent qualification design, data analysis, expiry extension, and release into commercial operations
• Manage reference standard small molecule and biologics inventory, including qualified reagents for analytical method or procedure use, and associated tasks
• Oversee reagent inventory levels and initiate replenishment and/or production activities
• Manage new critical reagents implementation projects
• Manage TrackWise records and investigations for Critical Reagents Group as record Owner, including Change Control (CC) records, equipment temperature excursion alarms (ARMS), and CAPA/CAPA EVs
• Support QC Specialized Shipping process to ensure the continuous supply of critical reagents and reference standards to Amgen QC and AS labs, Partner/Clients, as well as regional regulatory testing laboratories throughout the world
• Prepare complete, accurate, concise laboratory documentation and participate in laboratory documentation revision process
• Perform aliquoting and dispensing of critical reagents for laboratory use
• Perform general lab housekeeping and maintain inventory levels according to operational excellence principles
• Follow safety guidelines, cGMPs and ensures compliance with other regulatory requirements
• May provide technical guidance and train others as necessary
• Participate in audits, initiatives and projects that may be departmental or organizational in scope
• May represent the department/organization on various teams and interact with outside resources

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Senior Associate Quality Control professional we seek is an individual contributor with these qualifications.

THE BASIC QUALIFICATIONS ARE:

Master’s degree

OR

Bachelor’s degree and 2 years of Quality Control experience

OR

Associate’s degree and 6 years of Quality Control experience

OR 

High school diploma and 8 years of Quality Control experience

BEYOND THAT, THE PREFERRED QUALIFICATIONS ARE:

• Educational background in Chemistry, Microbiology, Biology or Life Sciences
• Laboratory experience in a GMP environment within the Pharmaceutical and/or Biotech industry
• Fully bilingual communications skills (English and Spanish)
• Good communications and presentation skills in English and Spanish
• Project management skills
• Strong organizational skills, including ability to follow assignments through to completion
• Enhanced skills in leading, influencing and negotiating
• Knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development
• Basic Knowledge and skills of word processing, presentations, and spreadsheet applications
• Available to support non-standard shift (including 1st, 2nd, 3rd and weekend shifts)

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we 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 maximize 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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