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Senior Associate Quality Control, Sample Management and Stability (Lab Support)

Employer
Amgen
Location
Holly Springs, North Carolina
Start date
Jun 1, 2024

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Job Details

HOW MIGHT YOU DEFY IMAGINATION?

Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds 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.

Senior Associate Quality Control, Sample Management and Stability

Live!

What you will do

Lets do this. Lets change the world. In this vital role you will be responsible for supporting the Quality Control Laboratory start up as a member of the QC Support Team. Responsibilities will include Sample management and Stability lab setup, validation of laboratory electronic systems and equipment, writing procedures and reports and ownership of QC Quality Records (Change controls, Deviations/CAPAs). Role may involve travel to support method or knowledge transfers. The Senior Associate QC Support will initially report to the Director of Quality Control. This individual will provide technical leadership in the QC Sample Management and Stability Laboratory. This role will support site start up and then transition to support manufacturing operations, and as such some extended hours, shift and weekend work may be vital.

Under minimal direction, the successful candidate will support the startup of the QC organization by:

  • Lead the QC Support team by developing/maintaining processes and procedures for sample handling and storage.
  • Assist in the development cGMP system for incoming and outgoing samples.
  • Assist in the development of cGMP system for stability samples. Preparing protocols and defining the process by which to stage/load samples and handle pulls.
  • Develop/oversee monitoring system for sample and stability storage units.
  • Own and handle Deviation, CAPA and Change Control records to support Quality Control.
  • Work collaboratively with site teams to establish work order and PM system for laboratory equipment.
  • Review validation documents to support equipment and computerized system onboarding for sample management lab.
  • Author, revise and review documents and reports including but not limited to SOPs, test methods, safety assessments, trend reports, qualification/validation summary reports, technical reports, method assessments, technical assessments, microorganism assessments.
  • Assist with procurement activities for consumables and critical reagents for lab start up.
  • Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.
  • Support routine activities over the weekends and public holidays as required.

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 effective leader with these qualifications.

Basic Qualifications:

  • High school/GED + 4 years of Quality experience OR
  • Associates + 2 years of Quality experience OR
  • Bachelors + 6 months of Quality experience OR
  • Master's

Preferred Qualifications:

  • Degree in a related scientific field such as Chemistry, Biochemistry, Physics or Chemical Engineering.
  • 4+ years of relevant laboratory experience in the GMP commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry and analytical testing experience preferred.
  • Proficient in the use of LIMS & LMES/CIMS.
  • Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery.
  • Strong written and verbal communication skills including technical writing and presentation.
  • Experience with equipment and method validation, verification, and transfer including the change control process.
  • Interact effectively with variety of communication and working styles and ability to work well in teams.

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

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
US

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