Job Description:
QA Specialist required for expanding biotech site. The successful candidate will have prior Validation experience in equipment, facilities and utilities in a GMP environment.
Required Skills and Qualifications:
* Site QA point of contact providing technical expertise, feedback and guidance for QA and compliance topics /issues including validation strategy /approach, new product introduction and manufacturing and assist in the resolution of issues commensurate with the level of risk.
* 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.
* Manage assigned areas of Quality Management System (QMS) to ensure the manufacture of product in accordance with GMP and regulatory requirements.
* Deviation investigations, Change Control and CAPA management systems; Internal/External audits; Vendor Management; review /approval Manufacturing Batch Records and assessment /approval of production materials.
* Generate, review, and approve SOP's/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.
* Ensure schedules for review and approval of GMP /validation documents are maintained to support technology transfers and new product introduction project timelines.
* Apply quality risk management principles including application of risk assessment tools such as FMEA.
* Act as QA lead in QA activities in project work-streams involving cross-functional, multi-department teams including Operations, Quality Control, Quality Assurance, Engineering, and others.
* Contribute to continuous improvement activities.
Benefits:
Work in a dynamic team and contribute to the success of an expanding biotech site. Develop your skills in a growing field with opportunities for professional growth and development.