Quality Operations Specialist III, Batch Disposition

If you find science, speed, and helping address serious infectious diseases exhilarating, you have come to the right place.

Individually, we're skilled, driven, and confident risk-takers.Collectively we're collaborative and accomplished. We're SuperNovas! Together we use our unique experiences, cultures, and learnings to turn innovation into reality while maintaining the highest standards. We value balance, encourage growth, and recognize that you are our most important asset. Build your future with us while bringing innovative vaccines to the world. We have a place for you!

Novavax, Inc (Nasdaq:NVAX) is a biotechnology committed to helping address serious infectious diseases globally through the discovery, development and delivery of innovative vaccines to patients around the world. We have more than a decade of experience contending with some of the world's most devastating diseases, and we are here to make a difference. Hard-won lessons and significant advances illustrate that our proven technology based on solid science tested by decades of research, has tremendous potential to make a substantial contribution to public health worldwide.

Novavax is seeking a Quality Operations Specialist for Batch Disposition at our Gaithersburg, MD site.

Essential Functions
* 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.
* Implement CAPAs as required
* Author and/or provide review and approval for generation of new or revised Quality SOPs and other controlled documentation. Author quality documents as assigned

- Responsible to ensure appropriate escalation, communication channels are used to ensure senior management are kept informed of critical issues, as required

- Responsible to ensure on time execution of activities and team timeline adherence

Required Knowledge, Skills, and Abilities

• Demonstrated ability to apply GMP, GLP, GCP and GCLP expectations

• Strong communication and organizational skills

• Knowledge in completing investigations and problem resolution

• Knowledge in SAP

• Able to effectively multitask

• The ability to produce high-quality work on complex problems with cross-functional involvement

• Must have strong ability to critically review investigations, results and provide technical conclusions consistent with Quality risk management principles

• Must be action-oriented and customer-focused and skilled in building relationships, problem solving, and planning

• Requires completing routine and complex tasks with little or no supervision

Education, Experience, Licenses & Certifications

• Bachelor's degree with 5 years of relevant GxP industry experience.

• Minimum of 3 years experience in batch review and release

• 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.