Senior Associate Quality Control
Location: Holly Springs
Posted on: June 23, 2025
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Job Description:
Join Amgens Mission of Serving Patients At Amgen, if you feel
like youre part of something bigger, its because you are. Our
shared missionto serve patients living with serious illnessesdrives
all that we do. Since 1980, weve helped pioneer the world of
biotech in our fight against the worlds toughest diseases. With our
focus on four therapeutic areas Oncology, Inflammation, General
Medicine, and Rare Disease we reach millions of patients each year.
As a member of the Amgen team, youll help make a lasting impact on
the lives of patients as we research, manufacture, and deliver
innovative medicines to help people live longer, fuller happier
lives. Our award-winning culture is collaborative, innovative, and
science based. If you have a passion for challenges and the
opportunities that lay within them, youll thrive as part of the
Amgen team. Join us and transform the lives of patients while
transforming your career. 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 What you will do Lets do
this. Lets change the world. In this vital role, you will perform
testing and assist with managing the Quality Control Bioassay
laboratory. The Specialist, Quality Control Bioassay will report
directly to the Senior Manager of Quality Control Bioassay. This
role may manage bioassay staff. Assist with planning and execution
of equipment installation and qualification within the Bioassay lab
to support startup. Responsible for operating QC bioassay
analytical testing for biologic products which includes ELISA and
cell-based methods. Leading transfer, qualification, and/or
validation for the complex biologic procedures. Author, revise, and
review documents and reports including SOPs, safety assessments,
methods, trend reports, qualification/validation summary reports,
technical reports, and method assessments. Assist with planning,
scheduling, and execution of daily activities. Work with external
partners to ensure successful transfer and release of and stability
testing. Support all operations of the Bioassay lab including the
ordering of supplies, maintaining of equipment and lab spaces.
Participate in audits, initiatives, and projects that may be
interdepartmental or global in scope. Own, manage, and participate
in deviations, CAPAs, and cross functional investigations. Training
of junior staff in bioassay techniques and assays. Assist with
general lab setup and 5S. Support routine activities over the
weekends and Amgen holidays as needed. What we expect of you We are
all different, yet we all use our unique contributions to serve
patients. The Specialist Quality Control Bioassay we seek is a
dynamic, flexible, and driven individual with these qualifications.
Basic Qualifications: High school diploma / GED and 4 years of
Quality Analytical testing experience OR Associates degree and 2
years of Quality Analytical testing experience OR Bachelors degree
and 6 months of Quality Analytical testing experience Preferred
Qualifications: Experience working in a GMP pharmaceutical
production facility with classified areas and applicable gowning
requirements. Degree in immunology, Biology, Biochemistry, or
related scientific field. Experience with cell-based methods and
ELISAs, with strong data analysis skills. Experience with equipment
validation. Strong knowledge of aseptic technique. Strong written
and verbal communication skills, including technical writing and
technical presentations. Able to flexibly work independently, as a
project owner, collaboratively on group tasks, and as a trainer.
What you can expect of us As we work to develop treatments that
take care of others, we also work to care for your professional and
personal growth and well-being. From our competitive benefits to
our collaborative culture, well support your journey every step of
the way. In addition to the base salary, Amgen offers competitive
and comprehensive Total Rewards Plans that are aligned with local
industry standards. Apply now and make a lasting impact with the
Amgen team. careers.amgen.com As an organization dedicated to
improving the quality of life for people around the world, Amgen
fosters an inclusive environment of diverse, ethical, committed and
highly accomplished people who respect each other and live the
Amgen values to continue advancing science to serve patients.
Together, we compete in the fight against serious disease. Amgen is
an Equal Opportunity employer and will consider all qualified
applicants for employment without regard to race, color, religion,
sex, sexual orientation, gender identity, national origin,
protected veteran status, disability status, or any other basis
protected by applicable law. 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.
Keywords: , Rocky Mount , Senior Associate Quality Control, Science, Research & Development , Holly Springs, North Carolina
