Covaxx, a subsidiary of the UBI Group, has joined the fight against COVID-19 and is rapidly developing precision antibody-based assays and vaccine candidates needed to successfully manage and slow the rate of the outbreak. As a result, Covaxx is quickly expanding to meet aggressive development and production goals, and is seeking to immediately hire a Quality Assurance Associate that will be responsible for conducting analyses and internal audits to assure conformance to quality regulations and participates in quality assurance studies. Quality Assurance Associate recommends revisions to, or creation of, new protocols, policies, procedures and/or systems as a result of the analysis.
Provide guidance to work teams to address quality requirements and improvement
Provide guidance on interpretation of regulatory requirements
Help maintain a state of “continual inspection readiness”, as well as specifically preparing for Vendor Qualification Audits, Regulatory Inspections, etc.
Ensure compliance with Quality System Regulations (QSRs) and ISO requirements
Make recommendations for actions to close compliance gaps as appropriate
Assist with corrective action as appropriate
Participate in inspections and assist with preparation of responses
Conduct audits on a periodic basis according to an established schedule/annual audit plan
Prepare written audit reports of all activities and report findings as applicable
May assist with meeting preparation, minutes, etc., preparation and presentation of reports
Provide assistance with and review of NCEs and CAPAs
Assist in maintaining and monitoring Quality Assurance specific quality indicators
Assist in the prompt and complete reporting of Reportable Quality Issues (RQI)
Participate in administrative functions of the QAU (e.g. updating records, maintaining spreadsheets, preparation of reports, filing, etc.)
Assist with Vendor Qualification activities
Help prepare the Quality Management Program Annual reports
Review controlled documents (SOPs, forms, etc.)
Write, review and/or revise QA SOPs
Assist the Document Control System Manager: troubleshoot issues, assist and advise staff
Knowledge and Experience:
Bachelor's degree in a related scientific or technical discipline, or equivalent
3+ years of hands-on experience in a QA function
3+ years of employment in a laboratory setting
Strong knowledge of GLP and/or GCP, Standard Operating Procedures, Document Control, and Quality Systems principles
Demonstrated knowledge of QA regulations and best practices
Excellent verbal and written communication skills; strong interpersonal skills, and a demonstrated ability to manage multiple activities while maintaining a high level of organization
Proficiency with Microsoft Office Suite; ability to utilize Excel for data analyses and production of charts and tables, including pivot tables; production of reports in Word, PowerPoint, etc., incorporating text and graphics
All candidates must be willing to work on a full-time basis at Covaxx’s headquarters in Hauppauge, New York.
By submitting your resume through this posting, you are authorizing the review of your resume, including name and contact information, solely by Covaxx, Inc. and/or its authorized representative as a prospective candidate for the position described. Your submission will be deemed strictly confidential, and in no circumstance will your personal information be provided to any other individual or company without your written consent. For further information go to: covid19searchpartners.com.
Long Island, Nassau County, Brooklyn, Queens, Brookhaven, Medford, Smithtown
About Covid-19 Search Partners
COVAXX is a subsidiary of UBI Group dedicated to the rapid development of diagnostics and vaccines to address urgent global health emergencies including COVID-19. For over 3 decades, the UBI Group has developed, manufactured and sold HIV, HCV, HTLV and FMDV blood diagnostic kits worldwide through various distribution partners. UBI has also developed, manufactured and sold over 4.5 billion vaccines, including approximately 500 million doses annually, through partners. Additional hiring needs are anticipated. Please continue to monitor the OPEN POSITIONS section of this website on a regular basis for updates.