Quality Systems Specialist
Novavax - Maryland

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Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative virus-like particle (VLP) and recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces potent vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India and LG Life Sciences of Korea. Together, these companies have worldwide commercialization capacity and the global reach to create real and lasting change in the biopharmaceutical field.

We are seeking a Quality Systems Specialist to join our Quality Systems group to perform a variety of activities to ensure the safety, quality, and efficacy of our product. The Quality System Specialist will be responsible for general support and maintenance of the Quality System within the requirements of FDA's Quality System Regulation (QSR). The primary duty for this individual will be to create and monitor laboratory investigations, process deviations and CAPA. Additional functions include write and revise standard operating procedures, change management, training, internal audits, and tracking and trending data. Duties for this position support manufacturing, quality control, quality assurance, product release, incoming material, and training.

Responsibilities include but are not limited to:

Create, monitor, review and approve laboratory investigations, process deviations and CAPA.
Track and trend Quality System Data.
Perform Root Cause Analysis.
Manage Change Management Program.
Review of change requests for content and completeness.
Generate or update standard operating procedures to define and improve quality system functions.
Revise existing documentation and processes to support continuous improvement.
Participate in the implementation and monitoring of the training program.
Interface with other departments regarding documentation requirements.
Participate in and support quality audits (internal and external), troubleshooting efforts, and other Quality System processes.
Provide back up and support to the Quality System Manager.

Minimum requirements:

Bachelor's Degree in a relevant life science field such as Biology, Microbiology, Chemistry, Biochemistry, etc.) with 5 -7 years of working experience in Quality Assurance and Quality Control or Manufacturing.
Previous professional experience with cGMPs and associated regulatory compliance requirements and guidelines for the manufacture, testing, and release of pharmaceutical or biopharmaceutical products.
Knowledge of FDA requirements including 21CFR210, 211, Quality System Requirements and ISO 9001.
Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirement are met.
Experience in compiling data to support metrics analyzing current processes.
Proficiency with Word, Excel and Power Point.

Additionally, we prefer candidates that have:

The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems.
Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action.
Must be able to correlate events and determine the action plan required to avoid incidents recurrence and or regulatory exposure.
The ability to organize, prioritize and deliver tasks projects with a sense of urgency under minimal supervision with neglecting attention to detail.
The ability to enable and drive change while being focused on internal and external customers.
The ability to communicate well both verbally and in writing with all levels both inside and outside of the organization.
Capable to manage multiple priorities.

This position may require periodic weekend/evening work.

Novavax, Inc. offers a base salary, annual bonus, stock options, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.

We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply.

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