Quality Assurance Specialist I/II, Materials (Temporary Assignment)

At Novavax, a clinical-stage vaccine company, we are creating tomorrow's vaccines today! We seek to attract, develop, and retain talented people who share our passion for science, medicine, and human health. We foster an environment of teamwork and collaboration, built on a culture that values and appreciates its employees. We are a fast-paced company that provides employees with opportunities to achieve personal and professional goals while also maintaining a balance between work and personal life.

The QA Specialist, Quality Operations, is responsible for support of GMP compliance with a focus on raw material release through provision of critical review, organization, and Quality oversight of records generated during receipt, testing, and disposition of materials intended for use in GMP manufacturing.

This is a temporary assignment for 6+ months.

Responsibilities include but are not limited to:

* Review of records generated during the disposition of received materials for compliance to material specifications, Novavax Standard Operating Procedures, and current Good Manufacturing Practices. Records include, but are not limited to:

* Material receipt, sampling, disposition, and chain of custody records.

* Supplier documentation (e.g. CofAs, CofCs, etc.)

* Review of records related to the general operation and upkeep of the various GMP Facilities, including but not limited to, records associated with:

* Equipment Logbooks

* GMP Cleaning Records

* Review of electronic records associated with capital assets

* Generation and reconciliation of disposition status labels.

* Interaction with Materials Management and end user groups to prioritize activities to ensure availability of materials.

* Maintenance of systems for organizing, tracking, and reporting facility log metrics.

* Primary Quality oversight for vial pulls and GMP related shipments

* Other duties as assigned

Minimum Requirements:

* Bachelor's degree in a scientific discipline.

* 0-2 years' work experience in Quality Assurance in a GMP regulated environment.

* Familiarity with GMP inventory control databases/MRP systems a plus.

* Proficiency with Microsoft Office and Outlook.

* Excellent multi-tasking and organizational skills.

Novavax, Inc. is a clinical-stage biotechnology company committed to delivering novel products to prevent a broad range of infectious diseases. Using innovative proprietary recombinant nanoparticle vaccine technology, we produce vaccine candidates to efficiently and effectively respond to both known and emerging disease threats. Our vaccine candidates are genetically engineered three-dimensional nanostructures that incorporate recombinant proteins critical to disease pathogenesis.

Our product pipeline targets a variety of infectious diseases, with clinical vaccine candidates for respiratory syncytial virus (RSV) and Ebola virus (EBOV), and preclinical programs for Zika virus (ZIKV), seasonal influenza and a combination respiratory vaccine candidate, as well as other infectious disease vaccine candidates.

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Rockville, Maryland and Uppsala, Sweden. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.

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.

Equal Opportunity Employer/Veterans/Disabled

Novavax, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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