Wayne M

Quality Coordinator - 15 Years of Experience - Near 33311


Quality Coordinator


Fort Lauderdale, FL

Education Level:

Some College Units Completed

Will Relocate:



Qualifications 12/2005 - 09/2016 Watson Labs/Actavis/Allergan/Teva Davie, Sunrise and Weston, FL Senior Controlled Substances Coordinator / Site DEA Compliance Specialist Compiled data, accurately complete and submit quarterly ARCOS and Year End Reports by established due dates. Continuously monitor the receipt of Controlled Substances and List 1 Chemical materials purchased to ensure the Quota is not exceeded. Continuously monitor Controlled Substances and List 1 Chemical documentation, hard copy (222 order forms, purchase orders, material transfer forms, quota certificates, bills of lading, import/export documentation, etc.) at the registered locations, ensuring accurate and compliant recordkeeping and retention. Assisted in the facilitation of product transfers and import/export activities. Coordinated the processes by which physical destruction of Controlled Substances are conducted by contract reverse distributor. Conducted regular internal self-audits of the registered locations controls and activities (record keeping, receipt, storage, handling, manufacturing, distribution, etc.) to ensure effectiveness in guarding against diversion, determine readiness for regulatory agency audits/inspections, compliance with applicable state/federal regulations. Coordinated annual Controlled Substance inventory for the registered location. Communicated timelines, requirements and provided support to internal stakeholders. Performed verification, ensuring inventories are accurate and completed for each registration by the established due dates. Represented the Company and registered location during DEA and other Controlled Substance regulatory agencies inspections. Authored and updated Controlled Substance Standard Operating Procedures for the registered locations - In Process Manufacturing Inspect and issue room equipment and component releases for different phases of manufacturing prior to entering packaging stage. Review and issue conditional releases full releases and quarantine of in- process products during different phases of manufacturing. Generate Hold Notices for non-compliant materials. Inspect and reconcile manufacturing batch records during and after manufacturing process to ensure the specifications and calculations are correct and cGMP practices are being followed prior to final in-process auditing before packaging stage. Perform in-process monitoring of tablets and encapsulation lots to ensure specification compliance. Perform AQL's and statistical sampling of out of specification product for final review and disposition. Trained new QA Inspectors and Manufacturing personnel on room equipment and component releases. Supervised two to four QA Inspectors on various shifts.





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