QA Specialist

Responsibilities

• Ensures compliance and assist in the implementation of Quality Management System (QMS), compliance to regulatory requirements, and GxP Standards (e.g. GDSP, GMP, GCP) as applicable
• Initiate and implement quality initiatives and programs for continual improvement
• Provides guidance to operational areas to ensure robust quality system
• Effectively write, review, and/or approve documented procedures (e.g. SOPs, Work Instructions, Protocols, etc.) to ensure quality assurance attributes are met
• Ensures proper documentation and archiving of QMS documents, along with maintaining traceability
• Act as the Qualified Person in compliance to FDA regulations (e.g. license-to-operate)
• Attends during regulatory inspections and customer audits
• Develop, revise, maintain, and implement Quality Assurance policies, programs, and procedures
• Conducts training of Quality Assurance related policies, progr...