Job Details

Job Description:

• The C&Q (Commissioning & Qualification) QA Floor Representative will provide direct quality oversight of commissioning and qualification activities for equipment, utilities, and facilities supporting pharmaceutical and combination product manufacturing.
• This role ensures compliance with regulatory expectations and quality standards during project startup and tech transfer phases, while partnering with cross-functional teams in a dynamic, high-growth environment.

• Provide real-time quality assurance (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 related to 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.

• Bachelor's degree in a relevant field (engineering, life sciences, etc.) or equivalent experience.
• Experience in quality assurance within pharmaceutical or medical device manufacturing, with a focus on commissioning and qualification activities.
• Familiarity with equipment qualification, facility validation, and utility systems (e.g., HVAC, WFI, 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.