Responsible for maintaining the Quality Management System, including; Standard Operating Procedures (SOP’s), Standardized Work Instructions (SWI’s), and other QMS documents, to establish and maintain current QMS in compliance with ISO 13485 and 21CFR Part:820 requirements.- Responsible for critical-to-quality specifications, test plans, procedures, tools, meaningful metrics and controls for all aspects of the organization.- Address customer complaints to identify, coordinate and effectively resolve problems in a timely manner- Develop plans and oversee the qualification of new and existing suppliers- Employ six sigma or other quality methodologies to resolve problems and provide continuous process improvement- Train others to build quality awareness in support of our quality policy and objectives- Conduct internal quality audits- Manage suppliers’ performance and conduct audits- Write and execute validation plans and protocols- Perform IQ/OQ/PQ on equipment and processes Responsible for managing cleanroom operations, maintenance, and cleaning activities per requirements of ISO 14644-1, Cleanroom Standards.

Responsible for wet and dry granulation processes and batch blending. Designed work instructions and SOPs. Performed new equipment IQ/OQ/PQ.

Manager of sterile filling processes, facility operations, sanitation and maintenance. Bulk Manufacturing, sterile filtrations and sterilization.

Sterile Filling Supervisor and Manager for Parke Davis/ Warner-Lambert. Responsible for lyophilization operations and sterile filling processes.