Performing quality systems, regulatory, and process improvement consulting and assistance for dietary supplement, pharmaceutical, medical device, and cosmetic manufacturers and distributors including:
o FDA cGMP compliance including 483 response plans
o Certification and compliance gap analyses
o Onsite audits and training
o QMS development including SOP creation and process implementation
o Label and formula reviews
o Regulatory compliance, review, risk analysis, and registration

-Lead operations for a personal care contract manufacturer including:
o Quality & Regulatory
o Product Development & Onboarding
o Customer Service and Purchasing
o Graphic Arts
o Production
o Warehouse & Logistics
-Developed and implemented all KPIs, COTs, Cost Standards, and Dashboards driving performance

• Lead implementation of QMS and GMPs in compliance to ISO 22716
• Implemented and improved quality control process and personnel
• Drove and maintained USDA NOP and NSF Organic Certification

• Lead a team of 27 scientists and technicians in a high volume and high paced lab performing quality release testing and method development for nutritional supplements in compliance with 21 CFR part 111.
• Capabilities included microbiology, HPLC, HTLC, IR, and ICP/GC-MS
• Drove all laboratory continuous improvement projects including lean six sigma projects and kaizens leading to an increase in lab OTD of testing of over 35%.

• Managed a team of QC microbiology technicians at two site laboratories in an ISO 22000 and 9001 certified large-scale fermentation probiotics plant.
• Lead quality troubleshooting teams driving FPFQ from 80% to over 97% and contamination rate from 13% to under 2%
• Lead CCP and oPRP validations including CIP, SIP, COP processes
• ISO 9001 and 22000 internal auditor; HACCP Manager and PCQI Certified

• Oversaw a team of 14 technical personnel in a high-paced contract laboratory performing various USP, EP, and ISO microbial assays including: antimicrobial efficacy testing, zone of inhibition assays, minimum effective concentration, environmental monitoring, bioburden, sterility, and D value testing.
• Directed gamma, EtO, and steam sterilization validations and product packaging qualifications.
• Wrote and approved protocols, work instructions, and controlled documents.

-Performed complex ISO and FDA 510k microbial testing including:
o Microbial ingress and contact lens solution assays
o Shelf life and stability testing
o Microbial differentiation and identification
-Performed routine QC microbiology testing supporting medical device and pharmaceutical release
-Maintained stock cultures, incubators, and laboratory instruments

-Supported solution and lens manufacturing areas
-Performed USP antimicrobial efficacy, biocidal, bioburden, sterility, and regimen testing on lenses and cleaning and storage solutions
-Validated steam sterilization processes and contact lens cleaning solution effectiveness

-Supported assay development of PCR diagnostic tests for oncological K-ras mutations, HIV-DNA and RNA, Cytomegalovirus, Hepatitis C Virus, Mycobacterium tuberculosis, and Mycobacterium avium complex assays
-Co-Invented method of DNA extraction from paraffin embedded tissue using a thermophilic protease and heat (Patented in US and Europe).