Senior Associate Quality Control, Sample Management and Stability
3 weeks ago
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.
Senior Associate Quality Control, Sample Management and Stability
Live
What you will do
Let’s do this. Let’s 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
Associate’s + 2 years of Quality experience OR
Bachelor’s + 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
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