Talent is working with a startup company that is looking to help cell and gene therapy companies meet their key product QC requirements by providing fast and actionable multi-parameter results using their tabletop instrument and a room temperature stable cartridge.
Our client is looking for a motivated quality documentation writer to be a Project Quality Manager. Using high quality documentation, you will manage process control of multiple products.
- Standardize high-level, as well as more detailed, quality procedures and work instructions (WIs), including creation of templates, where necessary.
- Review weekly updates to identify opportunities for process control and participate in quality team and cross-site meetings relevant to areas of responsibility.
- Help compile input for management review meetings.
- Assist the Director of QA and Regulatory Affairs in CAPA processing across sites.
- Providing input for drafting validation test design/protocols.
- BS or higher preferred in Life Sciences
- 5+ years of QA/regulatory work experience (knowledge of ISO 13485 manufacturing environment is ideal)
- Prior procedure writing experience
- Knowledge of CAPA process is an advantage
- Experience using and extracting data from a PLM or ERP is a major advantage