coco quality management
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Charles Coco Jr. has over 15 years of experience in quality management and laboratory management for highly regulated industries. He has a BS and MS in Chemistry and has held positions at companies such as Biotest Pharmaceuticals, Baxter Healthcare, Lonza Biologics, Genzyme Diagnostics, and DSM Catalytica. Currently, he works as an independent consultant providing services such as quality assurance reviews, auditing, quality systems improvement, and staff management.
coco quality management
- 1. Charles Coco Jr. 7562a Oxford Dr. St Louis MO 63105 (314) 677-7031 Cocojr03@gmail.com http://www.linkedin.com/in/charliecoco Summary Detail oriented Analytical Chemist and Integrity driven Leader with over 15 years of successful quality management, technical services and project management experience used to provide exemplary support to manufacturing, mentor and develop staff, form and strengthen cross functional relationships, assure an audit ready operation and realize cost savings through dedication to continuous quality improvement and a lean working environment. Qualifications 15+ years of quality and laboratory management experience within highly regulated industries. BS and MS degrees in Chemistry. Experience includes: o 24/7 staff management and development. o Establishing and maintaining quality control, quality assurance and regulatory compliance for laboratory operations within the constraints of Q7A, ICH, cGMP, cGLP, cGTP, EU, OSHA, EPA and ISO requirements. o Internal and external auditing experience includes - Quality laboratory point person hosting over 40 customer audits, countless internal audits and 4 FDA audits in the past 15 years with no 483’s or observations. Represented quality laboratories for new raw material supplier approvals and supplier auditing teams. Historic establishment and maintenance of an “audit ready” quality laboratory operation. o Responsible for laboratory deviations and CAPA resolution. o Commitment to continuous quality improvement and defect elimination using and training others in the use of tools such as DMAIC, TQM, Lean Labs, lean 6 Sigma, QIA, etc. o Laboratory operations historically managed/directed include: QC/QA, technical transfer and services, Bioanalytical, Analytical Development, EM, LIMS, Raw material groups, Laboratory support groups, Customer Service and Technical Support. o Industries have included API pharmaceuticals, polymers, dental monomers, biologics (Cell Culture mAB’s, Plasma Fractionation) and Medical Device. Experience Self Employed Independent Consultant and 3rd party contractor 2010- Present; 7/2006-2/2008 General project management and assistance, customer service, quality assurance reviews and auditing, laboratory deviation and CAPA resolution, ISO9001, TQM, Lean 6Sigma, Quality Control laboratory and Staff management principals and advise, stability studies, quality systems and procedural improvement project assessment, planning and implementation, SME consulting, etc. Clients/contracts have included: Tunnell Consulting The Oxford Group J&J, Janssen Biologics TASA Group Guidepoint Global Advisors Fibrogen General Nutrition Center City of Clayton MO
- 2. Biologics – Plasma Fractionation and cell culture Biotest Pharmaceuticals Feb 2008 to Jan 2010 Director of Quality Laboratories Boca Fl Training, coaching and development of a staff of 45, 7 direct reports. 24hour 5day operation. Product manufacturing and Customer service / support. Establishing and maintain an audit ready operation 21CFR600, 210/211. Laboratory QA and Regulatory responsibility. Laboratory CAPA and deviation remediation. Baxter Healthcare Dec 2003 – June 2006 Manager II, Quality Control Labs LA, CA Staff of approximately 45+ professionals. 6 direct, 24/7 support - 21CFR600, 210/211. Product and Customer support, laboratory QA and 6Sigma greenbelt training. Maintaining an audit ready operation while concurrently implementing quality system improvements. Lonza Biologics June 2002 to Dec 2003 Associate Director of Quality Control Portsmouth NH Technical transfer, analytical methods development, customer service, laboratory QA and Mfg support. Staff of 70+ employees (7 direct reports) 24/7. Assuring an audit ready operation under 21CFR600, 210/211, management of a quality systems improvement project and culture change. Resigned due to sudden and eminent downsizing. Medical Device – Test Kits Genzyme Diagnostics June 2001 to June 2002 QC Manager San Carlos, CA Responsible for a group of 10 in laboratory QA, regulatory and QC operations. Laboratory regulatory compliance operating under 21CFR210/211 and 800’s. Facility closure and operations moved to MA. Pharmaceuticals – API’s DSM Catalytica June 1999 to June 2001 QC Manager, CMO Palo Alto CA Managed eight to twelve 24/7 professional chemists and supervisors in QC laboratory assuring an audit ready operation, regulatory and quality assurance compliance (ICH Q7A GMP’s, CFR 210/211). Responsible for laboratory QA, IS, regulatory and QC operations. Remained for last batch during a facility closure after purchase by DSM. Specialty Chemicals – Polymers GE Power & Water Trevose PA June 1993 to June 1999 Research Scientist / Supervisor– Corp. R&D, Product Support(1997 – 1999) Senior Scientist – Corp. R&D, Product Support (1995 – 1997) Scientist – Corp. R&D, Product Support (1993 – 1995) Analytical methods development, global technical transfer, corporate product support representative for global emulsion and solution polymer products. o Implementation of ISO9000/ 14000 quality system. Education BS Chemistry Eastern University St. David’s PA MS Chemistry Saint Joseph’s University Philadelphia PA