Twenty-two years of operations and manufacturing experience including high precision machining, lighting, and commercial solid oral dosage forms. Experience with quality systems, root cause analysis and process qualification and validation. Experience with certification and regulatory requirement compliance including UL, FDA, ISO, and other global regulatory bodies. Experience with sampling and sub-sampling of liquids, powders, solids and semi-solids in support of validation and investigations. Responsible for authoring protocols and reports describing technical sampling schemes and data analysis. Authoring and approving Standard Operating Procedures and training outlines for technical, quality, and manufacturing personnel. Dedicated member of several project teams and have been lead technical scientist for the implementation of new manufacturing processes. Led the implementation of quality systems and processes for consumer goods lighting manufacturer. Reviewing site documentation for compliance with federal and international compendial requirements (e.g. USP, EU, and JP). Compliance with UL and global lighting test schemes and ISO9001 compliance. Experience working within a federally regulated industry (i.e. FDA and UL). Responsible for leading troubleshooting and remediation activities for equipment and product failures.