What are the responsibilities and job description for the Specialist, Quality Assurance position at ICONMA?
Our Client, a Clinical-Stage Cell Therapy company, is looking for a Specialist, Quality Assurance for their West Hills, CA location.
Responsibilities :
- Implementation of GMP Quality Operations
- Collaborate with key stakeholders and system owners on the continuous improvement of the Quality GMP processes at West Hills. Create and / or collaborate on corresponding SOPs.
- Represent Quality Assurance on project specific teams, as needed.
- Perform review and approval of executed batch records, and resolution of discrepancies with manufacturing personnel.
- Perform review and approval of Change Management deliverables.
- Perform review and approval of Deviation and CAPA record deliverables.
- Provide quality support for manufacturing operations in the cleanroom facilities (e.g., changeover / line clearance support, APH receipt, product pack-out, event triage).
- Perform review of final product lot file and lot disposition.
- Participate in QRM activities (e.g., serve as Quality representative for risk assessments)
- Perform review and disposition of incoming raw materials, and approval of raw material specifications.
- Author and / or collaborate on the creation and revision of Standard Operating Procedures across the West Hills site.
- Support other routine Quality operations as required, commensurate with experience and the West Hills site maturation.
