Specialist, Quality Control Microbiology
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. Specialist, Quality Control Microbiology What you will do
Lets do this. Lets change the world. In this vital role, you will
act as a Subject Matter Expert for PCR based assays, performing
testing as required, and providing general oversight within the
Quality Control Microbiology laboratory. The Specialist, Quality
Control Microbiology will report directly to the Senior Manager of
Quality Control Microbiology. Act as Subject Matter Expert for
method families and testing platforms used in the microbiology
department, specifically PCR based assays. Act as coach and mentor
for junior staff and perform training for microbiological
techniques and assays. Assist with scheduling and coordinate
STAT/rush requests from manufacturing. Perform PCR and other
microbiological assay testing as needed. Collaborate with Global
Process Owners to fulfill regulatory commitments. Represent the
microbiology department in audits, initiatives, and projects that
may be interdepartmental or global in scope. Work closely with the
global Quality Control organization to drive standardization of
testing processes and procedures. Represent Amgen while
participating in global forums relating to pharmaceutical
microbiological testing advancements. Author, revise, and review
documents and reports including but not limited to: SOPs, methods,
trend reports, qualification/validation protocols, microorganism
assessments, and technical reports. Lead method transfer activities
for new products, working with the Global Method Implementation
Team. Provide guidance on sampling strategies and in process
testing strategies for new products. Provide oversight of method
qualification and validation testing as needed. Lead process
improvement projects that may be local or global in scope. Own,
manage, and participate in laboratory investigations, deviations,
and CAPAs. What we expect of you We are all different, yet we all
use our unique contributions to serve patients. The Quality Control
Microbiology Specialist we seek is a dynamic, flexible, and driven
individual with these qualifications. Basic Qualifications: High
school diploma / GED and 10 years of Quality or Aseptic
Manufacturing experience OR Associates degree and 8 years of
Quality or Aseptic Manufacturing experience OR Bachelors degree and
4 years of Quality or Aseptic Manufacturing experience OR Masters
degree and 2 years of Quality or Aseptic Manufacturing experience
OR Doctorate degree Preferred Qualifications: Related experience in
the pharmaceutical industry, preferable working in a GxP
Microbiology lab. Degree in Microbiology, Biology, Biochemistry, or
related scientific field. Experience with microbiological quality
control testing, including but not limited to: PCR, Endotoxin,
Bioburden, Microbial Identification. Experience managing projects
with scope that encompasses multiple teams/stakeholders. Experience
with method qualification and validation. Experience with
instrument validation. Strong knowledge of aseptic technique.
Strong written and verbal communication skills, including technical
writing and technical presentations. Maintains a thorough
understanding of GxP Regulations and industry standards. Able to
flexibly work independently, as a project owner/manager,
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.
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