Quality Assurance Technician

Role Responsibilities

• 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.
• Proactively identify and address non-conformances in manufacturing operations.
• 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.
• Collections, reports and is responsible for departmental data.
• Alerts management promptly to any issues identified during batch production / record reviews that may adversely impact manufactured products, demonstrating accountability and a commitment to maintaining high-quality standards.
• 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.
• Has the ability to understand and demonstrate aseptic techniques and behaviors required in aseptic processing areas.
• Performs ERP transactions, as applicable.
• Must be willing to work overtime and weekends as needed to support business initiatives.

Basic Qualifications

• HS/GED.
• Bachelor's degree in a scientific field and industry experience is preferred.
• The individual must have strong attention to detail and organizational skills.
• The individual must be able to follow instructions and procedures.
• Basic knowledge of cGMPs (USFDA, Health Canada, PIC/S and/or Eudralex).
• Demonstrated decision making ability with emphasis on overall quality, site priorities, results and achievements.
• Works well in a team environment within own team and interdepartmental teams.
• Must work under short timelines while maintaining quality work.
• Must have effective written and oral communication skills.