Job Summary:
We are seeking a skilled Quality Assurance Specialist to join our team. The ideal candidate will have prior experience in validation, equipment, and facilities within a GMP environment.
Key Responsibilities:
* Provide technical expertise, feedback, and guidance on QA and compliance topics/issues.
* Review and approval of validation documentation and activities related to the qualification of facilities, equipment, and utilities.
* Manage assigned areas of the Quality Management System (QMS) to ensure product manufacture in accordance with GMP and regulatory requirements.
* Deviation investigations, Change Control, and CAPA management systems; Internal/External audits; Vendor Management.
* Generate, review, and approve SOPs/other documentation as applicable.
* Perform timely review and approval of site procedures and documentation to ensure compliance with GMP and regulatory requirements.
* Ensure schedules for review and approval of GMP/validation documents are maintained.
* Apply Quality Risk Management principles including risk assessment tools such as FMEA.
* Act as QA lead in project work-streams involving cross-functional teams.
* Contribute to continuous improvement activities.
About Us:
This is an exciting opportunity to work in a dynamic biotech industry.