QC Manager - Instrumentation
Company: FUJIFILM Holdings America Corporation
Location: Holly Springs
Posted on: March 17, 2023
Job Description:
Overview
The work we do at FDB has never been more important-and we are
looking for talented candidates to join us. We are growing our
locations, our capabilities, and our teams, and looking for
passionate, mission-driven people like you who want to make a real
difference in people's lives. Join FDB and help manufacture the
next vaccine, cure, or gene therapy in partnership with some of the
most innovative biopharma companies across the globe. We are proud
to cultivate a culture that will fuel your passion, energy and
drive - what we call GenkiWe are growing our locations and are
investing more than $2 billion into establishing a new -large-scale
manufacturing site for biopharmaceuticals in the United States to
accelerate the growth of our Bio CDMO (Contract and Development
Manufacturing Organization) business. This will be the largest
end-to-end cell culture CDMO provider in North America. The new
site will offer end-to-end solutions -to our customers looking to
manufacture biopharmaceuticals in the US. In addition to drug
substance manufacture, it will also -provide -automated fill-finish
and assembly, packaging, and labeling services. The new
state-of-the-art facility is located in Holly Springs, North
Carolina, United States. -We are looking for a QC Manager-
Instrumentation, who wants to participate in our journey to
establish the largest end-to-end cell culture CDMO facility in
North America. But more importantly, someone who wants to be a part
of the largest growth journey that we in FUJIFILM have ever
entered. -We offer the possibility of joining our dedicated team
with a focus on ensuring QC instrumentation and equipment meet the
needs of our new QC Laboratory to support the new cGMP
manufacturing facility.As the QC Manager- Instrumentation, you will
be assuring timely and high-quality equipment selection,
installation, qualification, service contracts, vendor relations,
software (including LIMS) and relevant SOPs to support cGMP
operations. You will be reporting initially to the Head of Quality
and will eventually report to the Head of QC. - You will join an
organization focusing on growth, people, and a steep learning curve
as well as a diverse workplace with people driven to make a
difference.
External US
Job Responsibilities
- Lead the QC Laboratory equipment selection, software, and
digital solutions -
- Ensure delivery and implementation of solutions which -fulfil
-requirements and expectations---by the end users -
- Build and maintain awareness and knowledge of regulatory,
legal, or quality requirements impacting the QC Laboratory
instrumentation and software
- Author and implement project plans, validation plans, user
requirements, and standard operating procedures
- Collaborate with our global partners to assure alignment within
our Fujifilm network.
- Report on status and manage escalations
- Ensure systems remain in a validated state and manage their
lifecycle from release to retirement
- Identify and capture new opportunities to improve or optimize
QC Lab systems -
- Ensure optimal quality inspections (internal and
external)Required SkillsWe are looking for a candidate with the
following background and skill sets:
- Master's or Bachelor's degree within IT, Physical, Chemical or
Biological Science, Technical Engineering or equivalent - -
- 8+---years---experience from similar role in large Pharma/
Biotech projects
- Experience in QC Laboratory equipment selection, qualification,
and managing service contracts
- Lead implementation and operations of LIMS
- Strong working knowledge of QC Laboratory equipment and
software
- Solid knowledge of Computer System Validation process
- Must be a self-starter, be able to work with minimal
supervision and effectively manage multiple projects
- Collaborative positive attitude with the willingness to work
with global peers toward company and department goals.
- Well versed in cGMP/ICH/FDA/EU regulations and guidelines
- Excellent oral and written communications skills in EnglishThe
Company requires that the successful candidate hired for this
position be fully vaccinated for COVID-19, absent being granted an
accommodation due to medical, pregnancy, or sincerely held
religious belief or other legally required exemption.FDBN works
with technical data, technology and materials that are subject to
U.S. export laws and regulations. This position will require access
to technical data, technology and source code that is controlled
under U.S. export laws and regulations, including but not limited
to the International Traffic in Arms Regulations at 22 C.F.R. Parts
120 - 130 and Export Administration Regulations in 15 C.F.R. Part
730 - 774, as may be amended. To conform to these laws and
regulations, applicants must be U.S. citizens, lawful permanent
residents of the U.S., protected individuals as defined by 8 USC
1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible
for an export authorization from the U.S. Department of State or
U.S. Department of Commerce. Offers of employment will be
contingent on the Company's ability to secure an export
authorization.FDBN is an Equal Opportunity Employer. All qualified
applicants will receive consideration for employment without regard
to race, color, religion, sex, national origin, disability,
protected veteran status, sexual orientation, gender identify or
any other protected class. If an accommodation to the application
process is needed, please email lena.lee@fujifilm.com.To all
agencies: Please, no phone calls or emails to any employee of
FUJIFILM about this requisition. All resumes submitted by search
firms/employment agencies to any employee at FUJIFILM via-email,
the internet or in any form and/or method will be deemed the sole
property of FUJIFILM, unless such search firms/employment agencies
were engaged by FUJIFILM for this requisition and a valid agreement
with FUJIFILM is in place. In the event a candidate who was
submitted outside of the FUJIFILM agency engagement process is
hired, no fee or payment of any kind will be paid.
Keywords: FUJIFILM Holdings America Corporation, Cary , QC Manager - Instrumentation, Executive , Holly Springs, North Carolina
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