QA Documentation Specialist II

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.

Job Summary

We are seeking a QA Documentation Specialist II to join our Quality Assurance Documentation Department. This position reports directly to the Sr. Manager, Quality Assurance Documentation.

This position will be a hybrid position. A minimum of 3 days working on site, two days working from home, when possible. This position will require periodic weekend/evening work.
Essential Functions

• Format and manage documents in the Orion Documentation System.

• Issue Lab Notebooks, Logbooks, Test Requests, Batch Records, and Protocols.

• Oversee reconciliation and review processes for documentation.

• Manage and process record retention and archiving.

• Support and coach customers in documentation practices.

• Contribute to continuous improvement activities.

• Assist in generating and tracking metrics related to documentation and records management.

• Work cross-functionally as the representative for their area and may lead cross-functional work

• Work outside of your direct area of expertise when necessary.

Required Knowledge, Skills, and Abilities

• Knowledge in principles and practices of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDPs)

• Demonstrated verbal and written skills

• Solid organizational and time management skills

• Strong communication and teamwork skills, with the ability to collaborate cross-functionally.

• Proficient in Windows-based software and word processing experience

• Demonstrate an understanding of the team's role within the larger organization and its impact on other areas.

• Demonstrate confidence in achieving deliverables requiring cross-functional involvement

• Capacity to produce high-quality work nd address issues with cross-functional impact.

• Mentor customers on best practices for documentation.

Education, Experience, Licenses & Certifications

• Minimum of a high school diploma with a Associates degree preferred

• 4+ years of Quality experience in pharmaceutical, biologics and/or vaccine manufacturing

• Minimum of 2 years documentation experience

The annual base salary (or hourly wage) for this position falls within the range of $66,100.00 - $82,600.00. However, the actual base pay offered may vary based on several individualized factors, such as market location, job-related knowledge, skills, and experience. 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.