| 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. Responsibilities: - 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
Work Setting: All candidates must be willing to work on a full-time basis at Covaxx’s headquarters in Hauppauge, New York. Confidentiality: 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 |
