Associate Quality Control, Environmental and Utilities Monitoring
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. Associate Quality Control, Environmental and Utilities
Monitoring What you will do Lets do this. Lets change the world. In
this vital role you will be performing testing within the Quality
Control Microbiology laboratory. Responsibilities will include
sampling and testing to support clean utilities qualification and
establishment of the environmental monitoring program to deliver
site start up and then transition to testing in support of Amgen
North Carolina commercial product release. Scope includes
in-process, release, stability and routine monitoring testing. The
Associate Quality Control, Environmental and Utilities Monitoring
will report directly to the Quality Control Specialist of
Microbiology. Support document review and authoring, including but
not limited to: SOPs, safety assessments, methods, trend reports,
microorganism assessments, and technical reports. Assist with
execution of EMPQ activities to support establishment of
environmental monitoring program. Perform routine environmental
monitoring and utilities sampling. Perform routine quality control
testing, including Bioburden, Endotoxin, Microbial Identification,
PCR, and TOC. Participate in audits, initiatives, and projects that
may be interdepartmental or global in scope. Participate in
deviations, CAPAs, and cross functional investigations. Assist with
general lab setup and 5S. Support routine activities over the
weekends and public holidays as required. Assist with clean
utilities performance qualifications, including water for
injection, clean steam, clean compressed air, oxygen, and carbon
dioxide distribution systems. Support routine activities over the
weekends and public holidays as required. Perform routine tasks
such as cleaning and inventory management. What we expect of you We
are all different, yet we all use our unique contributions to serve
patients. The motivated professional we seek is a quality control
professional with these qualifications. Basic Qualifications: High
School diploma/GED and 2 years of related GxP laboratory experience
OR Associates degree and 6 months of related GxP laboratory
experience OR Bachelors degree Preferred Qualifications: Experience
working in a GMP pharmaceutical production facility with classified
areas and applicable gowning requirements. Degree in Microbiology,
Biology, Biochemistry, or related scientific field. Experience with
microbiological quality control testing, including but not limited
to: Endotoxin, Bioburden, Microbial Identification, TOC, PCR.
Strong knowledge of aseptic technique. Experience with
environmental monitoring and clean utilities' monitoring.
Proficient in Good Documentation Practices. Strong written and
verbal communication skills, including technical writing and
technical presentations. Able to flexibly work independently with
minimal supervision and collaboratively on group tasks. 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: , Winston-Salem , Associate Quality Control, Environmental and Utilities Monitoring, Science, Research & Development , Holly Springs, North Carolina
