QA Specialist, Client Services
Northern New Jersey
An industry leading biopharmaceutical manufacturer is looking to make multiple hires to strengthen their production of cell and gene therapy products. These individuals will be a key asset to the team, providing accurate investigations, thorough written reports, and most importantly, be the point of contact between the company and a client.
By joining this organization now, you will be entering yourself into the emerging industry of cell and gene therapy! Additionally, you will have a front-row seat to learn the different processes that one of the leading cell and gene therapy organizations follow, setting yourself apart from many beginning in the field.
- Participate in tech transfer activity to ensure adherence to company quality system standards.
- Create, update, review and/or approve project related documents such SOPs, Batch release templates, label templates, batch records, change controls, etc. according to client requirements and project scope.
- Promptly and effectively communicate any successes, and challenges internally and externally with clients as appropriate
- 5+ years of QA experience within the life sciences, with strong focus in the manufacturing and/or testing of biologics preferred.
- Experience in writing, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required.
This position is the ideal role for someone looking to establish themselves within the emerging cell and gene therapy industry. Don't hesitate to apply today!