C&Q QA Floor Representative
RTP or Charlotte area, NC or Kenosha, WI
On-Site role

Our Client is seeking a C&Q QA Floor Representative to provide direct quality assurance oversight for commissioning and qualification activities related to equipment, utilities, and facilities in pharmaceutical and combination product manufacturing environments. This role ensures compliance with regulatory and internal quality standards during project startup and technology transfer phases, partnering with cross-functional teams in a dynamic, high-growth environment. The position is responsible for making real-time quality decisions to support GMP operations, reviewing and approving qualification protocols and reports, and supporting deviation resolution. Additional responsibilities include contributing to continuous improvement initiatives, assisting with regulatory inspection readiness and internal audits, and supporting onboarding and training of personnel. Candidates should have a bachelor’s degree in a relevant field or equivalent experience, a background in quality assurance within pharmaceutical or medical device manufacturing, and strong knowledge of cGMPs and regulatory expectations. Willingness to travel to support multi-site operations (including WI, NC, IN, and other U.S. locations) and a flexible schedule to support project-based and off-shift activities are essential.

MINIMUM QUALIFICATIONS

• Bachelor’s degree in engineering, life sciences, or a relevant field, or equivalent experience
• Experience in quality assurance within pharmaceutical or medical device manufacturing, focusing on commissioning and qualification activities
• Familiarity with equipment qualification, facility validation, and utility systems such as HVAC, WFI, and clean steam
• Knowledge of cGMPs, FDA, and EU regulatory expectations for qualification and validation
• Strong cross-functional collaboration and communication skills
• Willingness to travel as needed to support multi-site operations, including WI, NC, IN, and other U.S. locations
• Flexible schedule to support project-based and off-shift qualification activities

RESPONSIBILITIES

• Provide real-time QA oversight of commissioning and qualification activities, including IQ/OQ/PQ execution
• Make informed quality decisions on the floor to support timely equipment and system release for GMP operations
• Ensure adherence to regulatory and internal quality requirements for qualification and validation processes
• Review and approve qualification protocols, deviations, and final reports
• Support timely triaging and resolution of deviations arising during commissioning and qualification (e.g., ensuring minor deviations are closed within one week)
• Partner with engineering, validation, and operations teams to ensure robust qualification strategies and risk-based approaches
• Contribute to continuous improvement initiatives to enhance qualification processes while ensuring compliance
• Assist in readiness activities for regulatory inspections and internal audits
• Support onboarding and training of personnel involved in commissioning and qualification