Quality Control Analyst

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.

We are seeking a Quality Control Analyst to join our Quality Control team in Germantown, MD. Qualified individuals will be responsible for providing testing and technical support for Novavax’s clinical development product pipeline, regulatory findings, and operations related to the Quality Control Microbiology Testing group.

Responsibilities include but are not limited to:

• Support the overall scientific and technical efforts of the Quality Group as it pertains to Microbiology and Raw Material Testing.

• Provide oversight for Microbiology/Raw Material testing associated with OTLs and CMOs.

• Troubleshoot and investigate trends in Microbiology/Raw Material method performance associated with OTLs and CMOs.

• Write, review, and edit SOPs and reports.

• Support the activities of the Microbiology Laboratory including sampling and testing, analysis, and determining if the results meet acceptance criteria.

• Support the activities of the Raw Material Laboratory, including receiving and sampling of raw material test samples and retains and determining if results meet acceptance criteria

• Support Microbiology and Raw Material outsourcing of test samples including submission and shipping to outside testing labs (OTL’s), reviewing OTL results, and completing testing documentation.

• Support equipment cleaning and general laboratory maintenance for the Microbiology and Raw Material Laboratories

• Maintain inventory for consumables used in the QC Microbiology and Raw Material Laboratories

• Support quality-related events such as deviations, CAPA, OOS investigations, and change controls

• Review of data generated from Microbiology and Raw Material Testing.

• Support trending of EM and utility data

• Work cross-functionally with various internally (E.g.: Manufacturing, Quality Control, Quality Assurance and Validation) and externally (E.g.: CMOs, OTLs, etc.)

• Maintain accurate written records compliant with current GMP, GLP, and GDP requirements and company procedures.

• Attend general and/or cross-functional meetings as required.

Minimum Requirements:

• Bachelor’s degree in biological science. QC Microbiology experience required.

• 2+ years of years’ experience in a cGMP laboratory, preferably related to pharmaceutical/biotech operations industry

• Experience in working with GMP documentation including SOPs, deviations and assay protocols.

• Preferable strong technical background in general QC Micro and/or Raw Material Testing.

• Proficient in Windows based software including Excel and Word.

• Experience in sample and data tracking software such as quick base.

• Good communication (oral, written, presentation) and organizational skills.

• Ability to multi-task and work independently.

• Experience with LabVantage or other LIMS platforms a plus but not required.

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.