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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 Quality 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 
 Industries include: Pharmaceuticals, Biologics, Medical Device and Specialty Chemicals. 
 Establishing and maintaining an audit ready operation within the constraints of 21CFR210/211, 
21CFR600, 21CFR800, Q7A, ICH, cGMP/LP/TP, EU, OSHA, EPA and ISO. Supplier and internal auditing 
experience. 
 15+ years of Quality Management including Quality Control, Quality Assurance, Raw Materials, 
Laboratory, Analytical Methods Development, LIMS, and Customer and Technical Services 
management experience in highly regulated industries supporting manufacturing and R&D. 
 Author, review and approval of regulatory submission documentation including: 
510(k)’s(cfr807), PMA’s, CLIA, INDA’s, BLA’s, etc. 
 Project management including analytical methods development, international technical transfer, 
capital and/or expansion projects, ISO9000 deployment, new raw material introductions, TQM, DMAIC 
/ 6 Sigma, etc. 
 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. 
 BS and MS degrees in Chemistry. 6Sigma greenbelt trained. 
Experience 
Self Employed Independent Consultant and 3rd party contractor 2010- Present; 7/2006-2/2008 
 General project management and assistance, QC manufacturing and R&D support 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 improvements, project assessment, planning and 
implementation, SME consulting, Batch record review, SOP and methods author, review and approval, 
etc. Clients/contracts have included: 
Tunnell Consulting TQM/Lean- consultant 
J&J, Janssen Biologics INDA submission- consultant 
TASA Group Subject matter expert (Laboratory QC, QA and Reg) 
Guidepoint Global Advisors Laboratory management seminars and phone consult 
Fibrogen BLA data review, summary and submission 
General Nutrition Center Subject matter expert, coaching and counseling 
City of Clayton MO Center of Clayton Athletic Center
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. 
Education 
BS Chemistry Eastern University St. David’s PA 
MS Chemistry Saint Joseph’s University Philadelphia PA

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coco quality management resume dec102014

  • 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 Quality 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  Industries include: Pharmaceuticals, Biologics, Medical Device and Specialty Chemicals.  Establishing and maintaining an audit ready operation within the constraints of 21CFR210/211, 21CFR600, 21CFR800, Q7A, ICH, cGMP/LP/TP, EU, OSHA, EPA and ISO. Supplier and internal auditing experience.  15+ years of Quality Management including Quality Control, Quality Assurance, Raw Materials, Laboratory, Analytical Methods Development, LIMS, and Customer and Technical Services management experience in highly regulated industries supporting manufacturing and R&D.  Author, review and approval of regulatory submission documentation including: 510(k)’s(cfr807), PMA’s, CLIA, INDA’s, BLA’s, etc.  Project management including analytical methods development, international technical transfer, capital and/or expansion projects, ISO9000 deployment, new raw material introductions, TQM, DMAIC / 6 Sigma, etc.  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.  BS and MS degrees in Chemistry. 6Sigma greenbelt trained. Experience Self Employed Independent Consultant and 3rd party contractor 2010- Present; 7/2006-2/2008  General project management and assistance, QC manufacturing and R&D support 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 improvements, project assessment, planning and implementation, SME consulting, Batch record review, SOP and methods author, review and approval, etc. Clients/contracts have included: Tunnell Consulting TQM/Lean- consultant J&J, Janssen Biologics INDA submission- consultant TASA Group Subject matter expert (Laboratory QC, QA and Reg) Guidepoint Global Advisors Laboratory management seminars and phone consult Fibrogen BLA data review, summary and submission General Nutrition Center Subject matter expert, coaching and counseling City of Clayton MO Center of Clayton Athletic Center
  • 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. Education BS Chemistry Eastern University St. David’s PA MS Chemistry Saint Joseph’s University Philadelphia PA