Title: Quality Assurance Manager
Location: Santa Monica, CA
This cutting-edge biotechnology company focusing on cell therapy mainly homing in on T-cells and are searching for their next QA manager to join their team. The candidate will be responsible for ensuring quality systems procedures are in compliance as well as identifying and assessing quality and regulatory risks in activities and processing in accordance with regulatory agency guidelines/ company practices.
Roles and responsibilities:
- Evaluate Batch Documentation and ensure that all issues to release the product are resolved.
- Ensure that all CAPA's and Deviations are reviewed and approved of products for the U. S. and other countries
- Assisting internal and external audits and regulatory inspections from partners
- Execute a variety of activities to make certain that compliance with the applicable regulatory requirements and quality objectives.
- BS with 10 years of experience in GMP environment in Pharmaceutical/ Biotech industry
- OR MS with 6 years of experience with GMP in Pharmaceuticals/ Biotech industry
- Ensuring GMP will be in conformance to EU, US and ROW
- Worked with authoring, accessing and closing out investigations, Change control records and CAPA's
- Ability to conduct and manage external and internal audits
Please note contractors are offered benefits through EPM Scientific (healthcare, vision, dental, 401(k) on a W2 basis)
If you are interested in this QA Manager position, please do not hesitate to apply!!!