Sean Obrien

Senior Qc Qa Consultant @ELIQUENT Life Sciences

DE

Create and refine quality management systems, including standard operating procedures (SOPs), validation protocols, and documentation practices. • Develop revise and deliver engaging and effective training programs on aseptic processing principles, techniques, and procedures for all relevant personnel (e.g, manufacturing operators, quality control, maintenance) working with RABS and isolators. • Employ approaches such as Lean Thinking, Six Sigma, and Kaizen to streamline operations, eliminate waste, reduce process variation, and continuously enhance quality.• Investigate and analyze data related to quality to identify trends, areas needing improvement, and potential solutions.• Assess and mitigate cleaning validation concerns. • Identify potential risks in the manufacturing process and develop strategies to mitigate them, ensuring product safety and efficacy. • Design and implement hands-on aseptic gowning training, ensuring strict adherence to established procedures and regulatory requirements.• Drive continuous improvement of the overall site contamination control strategy, identifying gaps and proposing effective solutions.• Serve as a subject matter expert for preparation of regulatory inspections (e.g, FDA, EMA, other health authorities) related to aseptic processing, contamination control, and gowning.• Execute mock FDA inspections and QMS audits of sterile pharmaceutical and biopharmacutical manufacturing operations. • Conduct gap analyses against new or updated regulatory requirements.• Provide expertise and guidance to ensure CAPAs are robust, timely, and address the underlying issues.

Northeastern University

Masters of Science, Regulatory Affairs for Drugs, Biologics, and Medical Devices

University of Rhode Island

Bachelor of Science (BS), Microbiology, General