Quality Assurance Technician

Requirements

• Reviews manufacturing related documentation to ensure processes adhereance and compliance with approved SOP's and cGMPs.
• Performs inspection readiness walk-throughs, line clearance and in-process checks in support of manufacturing activities
• Provides QA support for manufacturing and testing activities including: shop floor oversight, deviation and laboratory investigations, change management, SOP revisions and batch documentation review
• Able to work in a team environment within own team and interdepartmental teams independently, with minimal guidance and under short timelines while maintaining quality work.
• Collects, reports and is responsible for departmental data.
• Reviews SOPs, Forms, Logbooks, and Master Batch Records to ensure accuracy and compliance with established procedures.
• Participates in internal GMP audits and supports customer and regulatory audits.
• Assists in training Quality Assurance colleagues.
• Performs ERP transactions, as applicable.