Roxanne Sisak

About Roxanne Sisak

Quality Assurance and Compliance are not for the faint-of-heart! As a Certified Quality Assurance Manager and Quality Auditor with 12 years of experience in regulated industries (pharmaceutical manufacturing, distribution, and higher education), I have identified and resolved a wide range of deviations and opportunities for improvement. While highlighting these issues may not win any popularity contests, it will certainly improve product quality and safety, a goal every Quality Assurance professional strives to achieve. However, I cannot achieve this critically important goal alone, instead, I help organizations build a culture devoted to quality, compliance, safety, and ultimately accountability. Contact Information: r••••••••@gmail.com : Audit Program Development: Launched compliance audit program, qualified and trained auditors, and designed comprehensive reporting on internal, external, and health authority inspection trends. Continuous Improvement: Revitalized incoming inspection, production line operations, and final product review and release; boosting production efficiency by 25% and reducing quality errors by 30%. Corrective and Preventive Action: Initiated CAPA task force to address deviations and product complaints via cross-functional collaboration, driving on-time resolutions and a 25% decline in quality errors. Regulatory Agency and Customer Liaisons: Managed over 100 successful customer, FDA, DEA, NABP, and ISO audits. Project Management: Represented Quality Assurance on the Project Management team for two business acquisitions, opening of a new distribution center, and launch of the organization\'s first Learning Management System. Training: Designed and delivered annual training on Current Good Manufacturing Practices, Incident Investigation, Root Cause Analysis, Introduction to Quality, Good Documentation Practices, Regulatory Agency Audits, and Adverse Events/Product Quality Complaints. Risk assessment: Developed risk assessment process to comply with ISO 13485. Earned American Society for Quality’s Risk Management Specialized Credential.

Experience

1. Senior Quality Assurance Manager

   Bionical Emas

   Jan 2026 — Present

Education

• University of Nevada-Las Vegas

  Master of Science (M.S.), Exercise Physiology

  2003 — 2005

• University of Nevada-Las Vegas

  Bachelor of Science (B.S.), Kinesiology and Exercise Science

  1998 — 2002

• University of Nevada-Las Vegas

  Master of Education (MEd), Curriculum and Instruction in Secondary Science

  2008 — 2010