Job Information
Amgen Senior Associate Quality Control ( Chemistry) 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 Chemistry
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 Chemistry lab start up and then performing qualification and routine testing to support the Holly Springs Facility. Responsibilities will include writing procedures and reports, executing activities to support initial lab equipment installation, qualification, and validation. Method transfers and training development as well as support of implementation of computerized systems. The Senior Associate QC Chemistry will initially report directly to the Director of Quality Control. This individual will be a subject matter expert on QC Chemistry Laboratory operations and testing. This role will 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:
Leading the QC Chemistry start up activities including system qualification and validation and method transfers.
Working collaboratively with site teams to establish work order and PM system for laboratory equipment.
Assisting with review of validation documents to support equipment and computerized system onboarding.
Assisting with crafting and collaborating on Data Integrity Assessments for computerized lab systems.
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, and technical assessments.
Assisting with procurement activities for consumables and critical reagents for lab start up.
Ensure successful training and method transfer activities for HPLC, UPLC, TOC and other related Chemistry bench top Equipment.
Own and manage Deviation, CAPA and Change Control records to support Quality Control.
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 an 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.
Solid understanding of laboratory techniques.
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