| Quality Assurance Lead (Onsite) || Boston, MA|| NO H1B at Boston, Massachusetts, USA |
| Email: ajitk@dmsvisions.com |
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From: Ajit Kumar, DMS Visions Inc ajitk@dmsvisions.com Reply to: ajitk@dmsvisions.com Hi, Hope you are doing well, Please find the job description given below and let me know your interest. Position: Quality Assurance Lead (Onsite) Location: Boston, MA Duration: 6+ months Job Description: We are seeking a Quality Assurance Lead for a long-term contract opportunity for Client at located in Boston, MA. This role will be located on the Northeast coast of the United States to join them in setting up, promoting, and maintaining the QA model for their sites. The client is now entering an exciting new chapter to expand and diversify its pipeline for the future, starting with oncology, specifically CAR-T cell-therapy, a transformative treatment of different types of cancer. Through recent acquisitions, they are propelling themselves into next-generation cell therapies. Qualified candidates will have a minimum of five (5) years of experience with CAR-T and ATMP. QA Lead Point of Care Center Responsibilities: Point-of-Care manufacturing site qualification and onboarding Point-of-Care manufacturing quality auditing and monitoring Point-of-Care Compliance development to enhance consistency. Performance oversight for point-of-care manufacturing partners by development of PoC quality oversight system applying the digital tools available, including: Setting up the quality management system for point-of-care manufacturing monitoring in alignment with EU and US regulatory guidelines, working together with the EU team. Maintain product quality oversight, creating consistency using CellPoints central site capabilities and data. The QA PoC consultant reports to the QA Director at Galapagos based in the central EU site. QUALIFICATIONS: Relevant masters degree At least 5 years of experience in a senior role within a GMP environment with thorough working knowledge of cGMP QA processes. Experience in a ATMP manufacturing setting is preferred. Experience in a commercial GMP manufacturing setting is preferred. Proficient in project management Able to travel for on-site visits to PoC sites for F2F interaction with stakeholders. Enjoys working in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities. Results-driven and can-do mindset, without compromising quality and compliance. Independent thinker and resourceful Strong interpersonal skills If you are interested, please share your updated resume and suggest the best number & time to connect with you. Ajit Kumar US IT Recruiter , DMS VISION Inc 972-645-5051 | dmsvisions.com/ | ajitk@dmsvisions.com 4645 Avon Lane, Suite 210, Frisco, TX 75033 www.linkedin.com/in/ajit-kumar-32142814a/ Keywords: quality analyst information technology Massachusetts Texas https://jobs.nvoids.com/job_details.jsp?id=550353 |
| ajitk@dmsvisions.com View All |
| 09:41 PM 21-Aug-23 |