Job Information
Amgen Sr Associate Quality Control in Holly Springs, North Carolina
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 site QC start up. As a member of the QC Support Team. Responsibilities will include sample management and stability lab set up, writing procedures and reports and supporting lab analysts with initial lab equipment installation, qualification, and validation. Role may involve travel to support method or knowledge transfers. The Senior Associate QC Support will report to the Manager of QC support. Responsibility will include leadership in the QC Sample Management and Stability Laboratory. This role will support manufacturing operations, and as such some extended hours, shift and weekend work may be necessary.
Under minimal supervision, the successful candidate will support the startup of the QC organization by:
Working collaboratively with site teams to establish work order and PM system for laboratory equipment.
Participate in review of 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.
Assisting with scheduling/coordinating vendors and sitting in during vendor IOQ.
Assisting with procurement activities for consumables and critical reagents for lab start up.
Establishing processes and procedures for sample handling and storage.
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 leader with these qualifications.
Basic Qualifications:
High school/GED + 4 years Quality and/or documentation, business process development/execution experience OR
Associate’s + 2 years Quality and/or documentation, business process development/execution] experience OR
Bachelor’s + 6 months Quality and/or documentation, business process development/execution experience OR
Master's
Preferred Qualifications:
Bachelor’s degree
Experience training employees
Experience with Smartsheets software
Able to work independently with clear and concise communication skills
Technical writing experience
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
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.