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Work Background
All Call Staffing FirmPresident/Owner
Nov. 2021Georgia, United StatesAudit Pharmaceuticals, Medical Devices, Medical Device Clinical Trials, Cosmetics, Supply Chain, Food and Cannabis
Cannon Quality Group, LLCQuality Systems Lead Auditor/Team Member
Oct. 2021California, United States
SGSLead Auditor Pharmaceuticals, Cosmetics, Medical Device
Apr. 2018Highlights
Supply Chain Management Cost & Economic Analysis Corporate-Start-ups
Voice of the Customer Standard Coordinator Sales/Research/Auditor
Process Identification Improvement Processes Travel/Consulting
Skilled Negotiator Production Solution Market/Competitor
Conflict Resolution Contract Law Data Analysis/Integrity Certifications: ISO 9001:2008, ISO 9001:2015, ISO 13485:2016, ISO 22716:2007, ISO 15378:2017, ISO 14971:2019 EXCiPACT, EFfCI, Certified in CMDCAS, IATA, TAPA (C-TPAT), FSMA (Food Safety Preventative Controls Alliance), MDSAP, Regulations (EU) 2017/745 of the European Parliament and Council of 5 April 2017
SGSLead Auditor Pharmaceuticals, Cosmetics, Medical Device
Jan. 2018 - Jan. 2022201 Route 17 North Rutherford, NJ 07070• Make relevant decisions concerning the audit process and for informing SGS to resolve issues outside the audit process.
• Collect and analyze sufficient information to provide a recommendation for certification, with authority over the control and performance of auditing activities.
• Lead a team of auditors in performing pharmaceutical, and supplier audits in conformance with the SGS Global/Local procedures.
• Determine (upon evidence gained during audits) whether manufacturers are following all relevant standards/regulations, and whether registration should be recommended or allowed to continue.
• Present SGS Standard Training Courses and, upon approval, deliver such courses in a tutoring role.
BSIAssessor
Apr. 2015 - Dec. 2018 12950 Worldgate Drive, Suite 800 Herndon, VA 20170 • Maintain and develop assessment-skills, technical and management system standards
• Lead encouraged and coached colleagues as needed; establish effective partnerships
• Recommend the issue, re-issue or with-drawl of certificates and recommend opportunities for improvement, plan, schedule, budget and prompt information to support services
• Prepare assessment reports and approve corrective active and preventative action plans
• Oversee managers and suppliers ensure processes are operating efficiently, and objectives are met
• Supervised and conducted over sixty eight (68) Rx 360 Audits/ ISO Audits in the USA, Mexico, New Mexico, Italy, London, Brussels, Frankfurt and Ludwigshafen Germany, Netherlands, Belgium, Paris, Basel and Sisseln Switzerland, Luxembourg, Barcelona and Portugal, Dominican Republic, Puerto Rico, Guadeloupe, El Salvador, Panama City, Panama Budapest Hungary / certificates-ISO 9001:2015/ISO 13485: 2016, Certified in CMDCAS, IATA, TAPA (C-TPAT), ISO 22716:2007, MDR, MDSAP, EXCiPACT, EFfCI, ISO 14971, ISO 14155:2020, ISO 11135:2014, ISO 11137-3:2017, (GAMMA, EO, Steam), ISO 15378: 2017, IEC 62304, Food and (Medical Device Regulatory-in progress). Types of audits conducted supply chain security, packaging, active pharmaceuticals, excipients, cGMP, GDP, Raw Materials/Basic Chemicals and oil/gas. Conduct audits that consist of classification of medical devices, safety and effectiveness requirements, application for medical device licenses, foreign manufacturers, and obligation to inform, distribution records, recalls and implant registration data tracking, serialization, SAP and ERP systems. At least 300 audit days conducted and travel 100%.
Alcon contractor (Astrix)Scientist II (Chemist)
Mar. 2014 - Apr. 2015Johns Creek, Georgia, United StatesTest and validate raw materials (polymers) for contact lenses.
Johnson & Johnson (Noramco Pharmaceuticals)Chemist
Apr. 2012 - Feb. 2014Athens, Georgia AreaA Quality Control/Assurance Chemist with at least fifteen years experience within the Pharmaceutical industry. Application skills include QOIS, LIMS, SAP, Track wise, Doc pace and Empower software tools. Maintain a 97% accuracy rate in laboratory testing. Excellent communication and customer service skills. Accustomed to writing investigations (root cause) reports. Trained in writing and implementing standard operating procedures. Currently completing a Masters in Project Management with emphasis in Risk Management from the Florida Institute of Technology. (Anticipated graduation 2015). Instrumentation: Titrando HPLC UV Karl Fischer DSC Malvern X-Ray Diffraction GC Mass Spect FTIR Wet/Bench Validation Stabilty Finish Product In-Process Raw Materials
Qualitest PharmaceuticalsChemist/Quality Systems
Oct. 2008 - Mar. 2012Test active pharmaceutical ingredients and raw materials to specified requirements utilizing USP and other governing methods.
PatheonChemist/Quality Analyst
Oct. 1999 - Oct. 20082110 E Galbraith Rd in Cincinnati, Ohio 45237• Standard’s Coordination delivering and purchasing standards for testing.
• Coordinated and conducted methods using European, Japanese, British, the United States
Pharmacopeia and the Food Chemical Codex.
• Lead and coordinated work between different groups; conducted on-the-job training courses (SOPs), participating and help with the planning of kick-off meetings for new drug projects.
• Coordinated with project managers the planning and execution of submission for new drug applications. Communicating with over twenty clients in teleconferences and via email.
• Lead routine and non-routine quality investigations on plant processes and process development activities using instrumentation such as FTIR, Karl Fisher, Wet chemistry, etc. Conducted validation using technical packages from customers and validated methods from the United States Pharmacopeia, European, British/Japanese Pharmacopeia and Food Chemical Codex.
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