Job Information
Amgen Sr Associate Quality Control Support 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 Support
Live!
What you will do
Let’s do this. Let’s change the world. In this vital role you will provide technical leadership as the Quality Control Support senior associate at Amgen’s FleX Batch Biologics Manufacturing Facility. This role will support the validation and day to day operations of the laboratory systems including LIMS, CIMS, LMES and establishment of support team business processes. Individual will report to the Manager of Quality Control Support and work with the global Master Data group to support paperless functionality of the labs.
Support Change Control and Validation of Laboratory electronic systems during facility start up.
Business subject matter expert for laboratory computerized systems
Establish and maintain computerized systems to support analytical testing in GMP laboratory including participation in validation activities for systems.
Collaborate with peers locally and globally to ensure compliant systems are in place for data management.
Assisting with review of validation documents to support equipment and computerized system onboarding.
Create and collaborate on Data Integrity Assessments for computerized lab systems.
Author, revise and review documents and reports including but not limited to; SOPs, qualification/validation summary reports, technical reports, method assessments, and technical assessments.
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 + 6 years of Quality work experience OR
Associate’s degree + 4 years of Quality work experience OR
Bachelor’s degree + 2 months of Quality work experience OR
Master's degree
Preferred Qualifications:
Degree in a related scientific field such as Chemistry, Microbiology, Molecular Biology, Physics or Engineering or Information Systems.
3+ years of relevant experience in the GMP commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry.
Previous laboratory experience.
Strong knowledge of validation of LIMS & LMES/CIMS.
Experience in a lead role, providing guidance to team members.
Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery.
Strong written and verbal communication skills including technical writing and presentation.
Familiar with authoring or owning change control records.
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
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.