REMOTE Quality Assurance Lead Consultant(EST)
Boston, MA 02108 US
Scope of the project
We are looking for a QA Lead PoC consultant located on the North East coast of the US to join us in setting up, promoting and maintaining the QA model for our Point of Care sites.
- 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 CellPoint’s central site capabilities and data.
The QA PoC consultant reports to the QA Director based in the central EU site.
Who are you?
- You have a relevant master’s degree
- With 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
- You are proficient in project management
- You are able to travel for on-site visits to PoC sites for F2F interaction with stakeholders
- You enjoy working in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities
- Result-driven and can-do mindset, without compromising quality and compliance
- You are an independent thinker and resourceful
- You have good interpersonal skills
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