Involved in the submission of several New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs) Investigational New Drug (IND) submissions, Formal Meetings with FDA, Pre-submission Meetings for Medical Devices, and Drug Master File (DMF) submissions.Conducted 50+ compliance audits in the areas of current Good Manufacturing Practices (cGMP) in the pharmaceutical, dietary supplement and food industries and Quality System Regulation (QSR) in the medical device industry in accordance with 21 Code of Federal Regulations.Successfully submitted and received clearance for 30+ Premarket Notification 510(k) Submissions for medical devices. Proficient in the use of the FDA eSTAR 510(k) submission process.Complete annual FDA Facility Registration and Listing for over 20+ drug manufacturers. Complete annual FDA Establishment Registration and Listing for over 20+ medical device manufacturers.Extensive experience in review and compliance of drug, medical device, dietary supplements, and food labeling requirements under 21 CFR.Assisted clients for compliance with Foreign Supplier Verification Program (FSVP) under 21 CFR.Provided support for several Expert Witness Reports in multiple Class Action Lawsuits.Conduct Remote Data Entry Audits for the Lymphoma and Leukemia Society on-going clinical trials.

Total responsibilities for manufacturing, packaging, maintenance, distribution, and inventory management, quality assurance, for natural and organic foods. Bottom line responsibility for total sales needs of $30M. Managed 100 employees with four managers, 14 supervisors and clerical staff. Total responsibility for company relocation from Rahway (40K sq.ft.) to Edison NJ (100K sq.ft.).Handled all aspects from architectural planning stage, bidding all general contractor material handling equipment) to completion of project.Completed project on time and under budget (1.4 million vs. 1.5 million) with no delay on customer shipments. Re-designed warehouse layout, stock receiving, order selection processes to reduce labor and increase efficiency and accuracy.Initiated and completed Organic Certification program (Quality Assurance International) to meet and exceed industry and governmental standards.Developed formal Sanitation Program to comply with all governmental requirements as noted in CFR Title 21.

Performed total assessment and systems upgrade of existing quality assurance program.Supervised analytical and microbial laboratory departments with a staff of six technical employees.Reviewed all formulations and scheduled production processes to identify potential areas of material and / or efficiency cost reductions.Instituted Plant Sanitation Survey that monitored and recognized deficiencies in Current Good Manufacturing Practices, CFR Title 21Initiated a HACCP (Hazard Analysis of Critical Control Points) program to maintain food safety and reduce generation of substandard products.