Quality Operations Specialist III, Batch Disposition

Sorry, this job was removed Sorry, this job was removed at 09:04 p.m. (CST) on Tuesday, Feb 04, 2025
Be an Early Applicant
Quince Orchard, MD
78K-102K Annually
Healthtech
The Role

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.

The annual base salary (or hourly wage) for this position falls within the range of $78,250.00 - $101,750.00. 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.

Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: Gaithersburg, MD
122 Employees
On-site Workplace
Year Founded: 1987

What We Do

We’re making a difference in the health of people around the world by producing next generation vaccines that are accessible to more people. We stand strong against infectious diseases and viral threats—our science grounds us, our technology pushes us forward, our commitment inspires us to achieve our hopes. We do this work for the greater health of people everywhere. It’s more than our job. It’s our passion.

Our Novavax Social Community Guidelines: https://www.novavax.com/social-media-community-guidelines

Similar Jobs

Gaithersburg, MD, USA
122 Employees
78K-102K Annually
Columbia, MD, USA
15318 Employees
Walkersville, MD, USA
89K-104K Annually

Ahold Delhaize USA Logo Ahold Delhaize USA

Software Engineer - Master Data Management

AdTech • eCommerce • Food • Marketing Tech • Retail
Hyattsville, MD, USA
10000 Employees
98K-152K Annually

Similar Companies Hiring

Zealthy Thumbnail
Telehealth • Social Impact • Pharmaceutical • Healthtech
New York City, NY
13 Employees
Cencora Thumbnail
Pharmaceutical • Logistics • Healthtech
Conshohocken, PA
46000 Employees
Stepful Thumbnail
Software • Healthtech • Edtech • Artificial Intelligence
New York, New York
60 Employees
By clicking Apply you agree to share your profile information with the hiring company.

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account