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Quality Assurance Specialist III, CMO Operations

Company: Novavax
Location: Gaithersburg
Posted on: November 20, 2023

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
* Represent the QA CMO/ CTL Management Team with cross functional project
* 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
* 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
* The accountability to have others' confidence in achieving deliverables that are
complex, requiring interaction with other members of the immediate team and
* 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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