Quality Assurance Specialist
We are seeking a highly skilled Quality Assurance Specialist to support the review and approval of validation documentation and activities related to the qualification of the facility, equipment, and utilities to support start-up and on-going manufacturing.
Key Responsibilities
* Review and approval of validation documentation and activities related to the qualification of the facility, equipment, and utilities.
* Manage assigned areas of the Quality Management System (QMS) to ensure the manufacture of product in accordance with Good Manufacturing Practice (GMP) and regulatory requirements.
* Generate, review, and approve Standard Operating Procedures (SOPs)/other documentation as applicable to your areas of responsibility.
* Perform timely review and approval of site procedures and documentation to ensure compliance with GMP and regulatory requirements.
The successful candidate will also be responsible for ensuring schedules for review and approval of GMP/validation documents are maintained to support technology transfers and new product introduction project timelines. Additionally, they will apply Quality Risk Management principles including the application of risk assessment tools such as Failure Mode Effects Analysis (FMEA).
This is a challenging role that requires strong analytical and communication skills. If you have a passion for quality assurance and a drive to deliver high-quality results, we encourage you to apply.