QA Operations SME
Company: FUJIFILM Holdings America Corporation
Location: Holly Springs
Posted on: January 24, 2023
We 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 QA Operations Specialist III, Drug Product
manufacturing (DP), who wants to participate in our journey to
establish the largest end-to-end cell culture CDMO facility in
North America. More importantly, someone who wants to be a part of
the largest growth journey that we in FUJIFILM have ever entered.
As the QA Operations Specialist III, you will directly impact the
validation and start-up of a fully automated $2 billion Greenfield
During the project phase, the QA Operations Specialist III will be
responsible to partner in the Quality oversight of Drug Product
manufacturing processes (formulation/fill) through to operational
readiness, as well as provide oversight of validation program
execution for these processes. You will collaborate within the DP
Quality team as well as with other project teams, and with QA
departments at other sites to align strategies and procedures.
Once in operations, you will continue to ensure that applicable DP
systems and processes are operated/maintained in a validated state
throughout their lifecycle, with a focus on consistent policy
administration, QA oversight of day-to-day activities and
resolution or mitigation of issues occurring during operation.
Additionally, you may participate in optimization or improvement
initiatives and support regulatory agency and third-party
You will report to the QA Lead Engineer for DP/FG, (Drug
Provide QA oversight and support of project deliverables in
accordance with governing processes, and procedures for the DP
Assess the impact of system and process modifications and maintain
oversight of change management processes to ensure Manufacturing
Systems are first validated and then maintained in a validated
state through startup and into commercial operation
Provide oversight and approval of system and process lifecycle
documentation, including risk and impact assessments, product,
process and equipment specifications, functional specifications,
traceability matrices, qualification protocols, validation plans,
and validation summary reports
Contribute to the development of QA procedures for the validation
approach and lifecycle documents for Manufacturing Systems
Contribute to the development of QA documentation, procedures, and
processes for operational readiness objectives and QA support of
manufacturing operations in cGMP regulated facility
Ensure that project and operational quality objectives are met
within desired timelines.
Participate in streamlining or efficiency improvement initiatives
with other FUJIFILM Diosynth Biotechnologies sites.
This role and the associated responsibilities will develop as the
project matures, and startup activities evolve into operations
We are looking for a candidate with the following background and
Collaborative attitude with the willingness to work with global
peers and cross-functional teams toward company and department
Education and experience appropriate to a Specialist level role in
Validation, cGMP manufacturing operations and/or Quality oversight,
in an FDA regulated facility, is required. A minimum of 3-5 years'
experience in a GMP quality role is required.
Excellent oral and written communications skills and fluency in
Working knowledge of ASTM E2500, Smartsheet and/or Kneat validation
software is a plus
Familiarity/understanding of validation of production equipment,
hygienic utilities, quality systems, automation, manufacturing & IT
Systems, and methodologies is a plus
Understanding of GAMP5, Data Integrity, and application of 21 CFR
Part 820 and Part 11 is a plus.
Understanding of one or more of the following processes preferred:
cell culture or fermentation
large-scale recovery processes
formulation and/or fill
finished goods manufacturing
Occasional opportunity for International and/or Domestic travel may
Training and/or familiarity with Quality Risk Management principles
The 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
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 email@example.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 , QA Operations SME, Other , Holly Springs, North Carolina
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