Quality Assurance Specialist III, CMO Operations
Company: Novavax
Location: Gaithersburg
Posted on: November 20, 2023
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Job Description:
Description Title: QA Specialist III, CMO - Quality
Operations
Location: Hybrid
If you find science, speed, and success exhilarating, you have come
to the right place.
Novavax, Inc.(Nasdaq: NVAX) is a biotechnology company that
promotes improved
health globally through the discovery, development, and
commercialization of innovative
vaccines to prevent serious infectious diseases. Novavaxis
currently conducting multiple
late-stage clinical trials for NVX-CoV2373, our vaccine candidate
against the virus that
causes COVID-19, and has recently reported exciting and highly
encouraging initial
efficacy results. NanoFlu, our quadrivalent influenza nanoparticle
vaccine, met all primary
objectives in its pivotal Phase 3 clinical trial in older adults.
Both candidate vaccines
incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to
enhance the
immune response and stimulate high levels of neutralizing
antibodies.Novavaxis a
leading innovator of recombinant vaccines. Our proprietary
technology platform
leverages the power and speed of genetic engineering to efficiently
produce highly
immunogenic nanoparticles in order to address urgent global health
needs.
Novavax, Inc. is headquartered in Gaithersburg, Maryland with
additional facilities in
Uppsala, Sweden and Bohumil, Czech Republic.
We are seeking a Quality Specialist III to join our Quality
Assurance Operations team in
Gaithersburg, MD. The specialist will be responsible for support of
GMP compliance with
a focus on Manufacturing. The candidate will provide critical
review, organization, and
Quality oversight of records generated during GMP manufacturing,
release and stability
testing of biotechnologically produced vaccines, as well as
analytical records and data
generated for studies conducted under GCLP and GLP
guidelines/regulations. This
position will require periodic weekend/evening work and travel.
** Available for domestic and international travel, as required by
the business. **
Summary of the Position:
The Contract Manufacturing Organization team is seeking a QA
Specialist III to support
the CMO Quality Team. You will evaluate and review clinical and/or
commercial batches
for our vaccine's portfolio. You will make sure that product and
manufacturing process
records are within the specifications established and include
complete information
relating to the production and control of each batch or finished
product.
As a QA Specialist III, you are responsible for Batch Record Review
quality activities in
accordance with cGMPs, Novavax policies, standards, and procedures.
You will also be
responsible to work towards team and business goals.
Responsibilities include but are not limited to:
* Review of quality records and data generated during the
manufacturing and/or
testing of vaccines for compliance to current Good Manufacturing
Practices
(cGMP), Good Laboratory Practices (cGLP), Good Clinical Laboratory
Practices
(GCLP) and Novavax Standard Operating Procedures (SOPs) and
protocols.
Records and data include, but are not limited to:
o cell banks records
o virus stocks records
o drug substance batch records
o drug product batch records
o other(s) related documentation
* Review and approval of executed batch records.
* Ensure all records and documentation related to the executed
batch record(s) for
completeness, accuracy, and compliance of cGMPs and Novavax
SOPs.
* Provide Quality support for resolution of deviations related to
manufacturing
activities and department. Maintain oversight of deviations within
department.
* Be aware of Change Controls impacting CMOs
* Implement CAPAs as required
* Maintain department metrics
* Author and/or provide review and approval for generation of new
or revised
Quality SOPs and other controlled documentation. Author quality
documents as
assigned
* Represent the QA CMO/ CTL Management Team with cross functional
project
teams
* Review and approval of manufacturing technology transfer,
qualification, and
validation documents internally and oversight activities to
CMOs
* Establish tracking system and proactively request batch records
and disposition
materials based on expected turnaround times and quality
agreements.
* Able to effectively multitask
* Responsible to ensure appropriate escalation, communication
channels are used
to ensure senior management are kept informed of critical issues,
as required
* Management of critical issues and timely resolution, developing
solutions to
complex situations
* Responsible for identifying risks and communicating gaps for GMP
processes in a
timely manner
* Responsible to ensure on time execution of activities and team
timeline
adherence
* Support health authority inspections as required
* Perform SAP transactions as required
* Facilitate continuous improvement projects and improves
efficiency and
productivity within the team
* Ensure compliance by maintaining training completion on time
Perform any other job-related duties as requested by management
Minimum requirements:
* Bachelor's degree in science
* Minimum of 3 years of GxP industry experience
* Excellent understanding of Quality Assurance systems
* Strong communication and organizational skills
* Demonstrated ability to apply GMP, GLP, GCP and GCLP
expectations
* Knowledge of global regulatory expectations (including FDA and
EMA).
* The established recognition within QA as a technical expert
* Requires completing routine and complex tasks with little or no
supervision
* Must be highly motivated, well organized, and detail-oriented
person
* Must be action-oriented and customer-focused and skilled in
building
relationships, problem solving, and planning
* Must have strong ability to critically review investigations,
results and provide
technical conclusions consistent with Quality risk management
principles
Preferred requirements:
* Demonstrated knowledge in completing investigations and problem
resolution
* Demonstrated interest and ability to manage technical,
operational, and
administrative aspects of the team
* Demonstrated ability to apply GMP, GLP, GCP and GCLP
expectations
* The flexibility to strategize a new direction of his/her work
when change is
encountered or necessary; to help teammates with their own agility
in a changing
context
* The accountability to have others' confidence in achieving
deliverables that are
complex, requiring interaction with other members of the immediate
team and
beyond
* The ability to produce high-quality work on complex problems with
crossfunctional involvement; to anticipate and proactively prevent
risks and
compromises to quality
* The capability to recognize inefficiencies in the team and
identifies improvements
constructively; to work across teams effectively and frequently
collaborate on
other business areas
Novavax is headquartered in Gaithersburg, Maryland with additional
facilities in Uppsala,
Sweden and Bohumil, Czech Republic. Novavax is traded on the Nasdaq
Stock Market
under the symbol NVAX and is dedicated to developing novel vaccines
to address
infectious disease.
Novavax offers a base salary, annual bonus, equity grants,
professional career
development/growth opportunities, and a comprehensive benefits
package including
medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k)
plan.
Equal Opportunity Employer/Veterans/Disabled
Novavax is an equal employment opportunity employer. Employment and
advancement
opportunities are available to all individuals on an at-will basis,
regardless of their race,
color, national origin, religion, ancestry, citizenship status,
military or veteran status, sex,
sexual orientation, gender identity or expression, age, marital
status, family
responsibilities, pregnancy, disability, genetic information,
protective hairstyle, or any
other characteristic protected by applicable federal, state, or
local law.plicable federal, state, or local law. Equal Opportunity
Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner
discriminate against employees or applicants because they have
inquired about, discussed, or disclosed their own pay or the pay of
another employee or applicant. However, employees who have access
to the compensation information of other employees or applicants as
a part of their essential job functions cannot disclose the pay of
other employees or applicants to individuals who do not otherwise
have access to compensation information, unless the disclosure is
(a) in response to a formal complaint or charge, (b) in furtherance
of an investigation, proceeding, hearing, or action, including an
investigation conducted by the employer, or (c) consistent with the
contractor's legal duty to furnish information. 41 CFR
60-1.35(c)
Keywords: Novavax, Washington DC , Quality Assurance Specialist III, CMO Operations, Other , Gaithersburg, DC
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