C&Q QA Floor Representative
C&Q QA Floor Representative
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Salary Not Disclosed
1 Vacancy
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.
- Bachelors 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.
Employment Type
Full-time
