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Specialist Quality Control

4 months ago

Holly Springs, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Specialist, Quality Control Bioassay

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will perform testing and assist with managing the Quality Control Bioassay laboratory. The Specialist, Quality Control Bioassay will report directly to the Senior Manager of Quality Control Bioassay. This role may manage bioassay staff.

  • Assist with planning and execution of equipment installation and qualification within the Bioassay lab to support startup.

  • Responsible for operating QC bioassay analytical testing for biologic products which includes ELISA and cell-based methods.

  • Leading transfer, qualification, and/or validation for the sophisticated biologic procedures.

  • Author, revise, and review documents and reports including SOPs, safety assessments, methods, trend reports, qualification/validation summary reports, technical reports, and method assessments.

  • Assist with planning, scheduling, and execution of daily activities.

  • Work with external partners to ensure successful transfer and release of and stability testing.

  • Support all operations of the Bioassay lab including the ordering of supplies, maintaining of equipment and lab spaces.

  • Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.

  • Own, manage, and participate in deviations, CAPAs, and cross functional investigations.

  • Training of junior staff in bioassay techniques and assays.

  • Assist with general lab setup and 5S.

  • Support routine activities over the weekends and Amgen holidays as needed.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The quality control professional we seek is a leader with these qualifications.

Basic Qualifications:

  • High school diploma / GED and 10 years of Quality Analytical testing experience OR

  • Associate’s degree and 8 years of Quality Analytical testing experience OR

  • Bachelor’s degree and 4 years of Quality Analytical testing experience OR

  • Master’s degree and 2 years of Quality Analytical testing experience OR

  • Doctorate degree

Preferred Qualifications:

  • Experience working in a GMP pharmaceutical production facility with classified areas and applicable gowning requirements.

  • Degree in immunology, Biology, Biochemistry, or related scientific field.

  • Experience with cell-based methods and ELISA’s, with strong data analysis skills.

  • Experience with equipment validation.

  • Solid understanding of aseptic technique.

  • Strong written and verbal communication skills, including technical writing and technical presentations.

  • Able to flexibly work independently, as a project owner, collaboratively on group tasks, and as a trainer.

Thrive

What you can expect of us

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.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now

for a career that defies imagination

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

careers.amgen.com