QA Specialist - Operations
A leading CDMO is looking to bring on a QA Specialist to join their site in Allendale, NJ. They are dedicated to the production of cell and gene therapy products and was one of the first CDMO's worldwide to manufacture a commercial cell therapy. They are looking for an individual who is enthusiastic about learning and wants to grow with the company. With how quickly they are expanding, it is an ideal position to show off your leadership skills with a company that values each individual member of their team.
- Proactively identifies risk and prepares mitigation strategies associated with project and client work.
- Represents QA Client Services during scheduled meetings with client and cross functional department.
- Ensures all necessary quality documents are closed prior to batch released; responsible for batch released on timely manner according to schedule.
- Draft initial Quality agreement and complete necessary revisions based on client and company requirements.
- Promptly and effectively communicates any successes, challenges, and/or constraints internally and externally with clients as appropriate.
- Provides quality data to Project Manager for the purpose of creating KPI metrics.
- Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required.
- Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.
- Working knowledge and technical understanding of aseptic manufacture of biologics preferred.
If this sounds like a good fit, please don't wait to apply!