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REMOTE Quality Assurance Lead Consultant(EST)

Boston, MA 02108

Posted: 08/24/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 580282 Is job remote?: Yes Country: United States

Job Description


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.

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 CellPoint’s central site capabilities and data.

The QA PoC consultant reports to the QA Director based in the central EU site.
Job requirements
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

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Boston, MA

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Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.