What are the responsibilities and job description for the Senior QC Analyst position at Novavax, Inc.?
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.
The Quality Control Senior Analyst is responsible for day to day operations related to release and stability testing, maintaining QC cell culture lines, and writing SOPs, deviations, change controls and CAPAs as part of typical QC operations.
Responsibilities include but are not limited to:
Performs GMP release and stability testing in Quality Control
Write technical reports and supporting documentation such as deviation, reports, testing protocols, and trend analyses
Review of laboratory notebooks, protocols and reports
Perform day to day activities for cell propagation used for QC release and stability assays.
Participate in technology transfer, method qualification and validation
Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines
Participate in internal assessments and regulatory audits as required
Ensure that written records and work undertaken are performed in accordance with cGMP and company procedures
Leading the lab in 5S and routine housekeeping activities
Maintain effective communication with other relevant groups, including but not limited to Quality Assurance, Manufacturing and Analytical Development
Other duties as assigned
Minimum requirements:
Minimum of a Bachelor's degree or equivalent in a scientific discipline
Minimum 8 years of industry experience in a cGMP laboratory, preferably related to biopharmaceutical industry operations
Hands on experience performing ELISA in a cGMP environment
Hands on experience performing SDS-PAGE in a cGMP environment
Working knowledge of Sf9 Insect Cell Culture Procedures and cell-based assays e.g. HS plaque and Rapid Titer assay
GxP (regulatory relevant skills and knowledge) GLP/GCP/GMP required
Excellent analytical skills and knowledge
Strong troubleshooting skills for equipment and software
Solid ability to work independently (minimum supervision)
Ability to lead others, as needed
Ability to effectively collaborate with others
Excellent communications skills and be conversant in computer systems
Excellent multi-tasking and organizational skills.
Excels in time management
Strong attention to detail
Job holder should be a good understanding of relevant regulatory/industry standards and requirements
