Charles Coco Jr. has over 15 years of experience in quality management and analytical chemistry. He has an MS in Chemistry and is a Six Sigma Greenbelt. He is currently working as a Quality Manager for General Nutrition Center, where he establishes KPIs and ensures regulatory compliance. Previously he held various quality leadership roles at biologics and pharmaceutical companies, where he developed analytical methods, managed quality laboratories, and drove continuous quality improvement initiatives.

1. Charles Coco Jr.
7562a Oxford Dr. St Louis MO 63105 (314) 677-7031 Cocojr03@gmail.com
http://www.linkedin.com/in/charliecoco
Summary
Integrity driven quality laboratory leader and analytical chemist with over 15 years of successful quality
management experience used to 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 envirnment.
Qualifications
 MS degree in Chemistry (analytical/instrumental concentration),6 Sigma greenbelt trained, analytical
methods development expert and laboratory management QA/QC consultant.
 15+ years of cGMP quality laboratory management experience.
 Hands on and management of analytical methods development activitiesand chemists throughout
entire career. Including: HPLC,GC, spectroscopic,IC, AA, GPC/SEC, NMR, etc.) analysis of all raw
materials, bench,pilot and fullscale mfg support, tech transfer support / transfer of methodology,
efficacy testing,etc.
 Management responsibility for the following groups: QC/QA, raw materials, analytical methods
development and tech transfer, LIMS, Customer and TechnicalServices. Groups have been both
corporate and plant based supporting R&D, customer service and mfg.
 Experienced in establishing and maintaining an audit ready operation assuring compliance with GLP,
cGMP,GTP,USP, CFR, ISO, ICH guidelines, SOP’s etc. Quality Laboratory management representative
for 4 successful FDA audits withno 483’s; hosted over 5 dozen customer audits. Conducted new raw
material supplier audits as part of a team for over6 years.
 Laboratory QA responsibility includes quality systems, audits, deviation management and CAPA, risk
assessment and management, documentation and compliance, training, establishment, controlled
documentation- laboratory sections of submissions, 510(k)’s(cfr807),PMA’s, CLIA, INDA’s, BLA’s, etc.
 Commitment to continuous quality improvement and defectelimination using and training others in
the use of tools such as DMAIC, TQM,Lean Labs, lean 6 Sigma, QIA, etc.
 Establishment and monitoring of KPI’s, control limits and specifications utilizing SPC (process
capability, xMr, etc.). Established at corporate/pilot and transferred to international facilities to
harmonize mfg operations.
 Established record of implementing positive cultural change while driving exemplary support and
continuous quality improvement forexisting operations.
 Quality management experience has spanned the entire life cycleof the product. Ie. Raw material
evaluations/approvals/supplier audits provided lab support forR&D, pilot runs and plant (methods
development/tech transfer) Finished product specification establishment, control and product
release (QA, testing and SPC) -> International harmonization of product quality (Productsupport)
Increased process efficiency and implemented continuous quality improvement measures (SPC,
ISO9000 deployment, lean, QIA, TQM/DMAIC/6Sigma)  provided and assured exemplary customer
and technical support..…
Cross functional experience throughout the life cycle of the product.

2. Experience
General NutritionCenter Supplements Sept 2014- Present
Quality Manager MultipleSt. Louisstores
 Management training, product efficacy andgeneral healthcare training, technical/customer service,
quality and systemic investigations, quality improvement/TQM, project management.
 Established local KPI’s and monitored corporate KPI’s to assess employee and store success vsgoals,
provide documentation for accountability and staff development and training.
 Current project includes market expansion and training of new associates and management.
IndependentConsultant/Contractor Feb2010-Sept2014
QualityAssurance,QualityControland Projectmanagementconsultant– numerousclients
 General employee quality and management training, project management assistance, quality assurance
reviews and auditing, laboratory deviation and CAPA resolution, ISO9001, TQM, Lean 6Sigma, 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, coachingand counseling
City of Clayton MO Center of Clayton Athletic Center
BiotestPharmaceuticals mAB’sandPlasma– BiologicsCMO Feb 2008 to Jan 2010
Directorof Quality Laboratories Boca Fl
 Responsible forquality laboratories providing support for manufacturingand R&D including analytical
and immunology labs, Micro,stability group, Raw Materials, LIMS, environmental monitoring, Med
Techs, Analyticalmethods development, QCin process and product lotrelease groups. Sr. analytical
development chemists reporting direct , as always, tomaintain tight development team.
 AnalyticalProjectmanager for new product introductionsand international producttechnicaltransfer.
 Training, coachingand development of a staff of 45, 7 direct reports (4 managers, 1 supervisor and 2
senior analyticaldevelopment chemists, 30+ MedicalTechnologists and chemists); 5day operation.
 Continuous Quality Improvement recommendations fromstaff made mandatory. Cross functionalteams
were developedto eliminate process inefficienciesgoinginto and out of the laboratories including
moving costeffectivetesting directly ontothe manufacturing floor.
 Assured strict Laboratory Regulatory and Quality Assurance compliance(cGMP/GLP/GTP,ICH,etc),
CAPA remediation; establishment and maintenance of audit ready operating groups.
 Left forfamily reasons.
IndependentConsultant/Contractor July2006 – Dec2008
 Technical transfer assistance, Laboratory quality assurance regulatory submission document reviews,
Deviation and CAPA resolution assistance, stability projects, management training, methods
development and analytical methods transfer assistance, etc. – numerous customers.
 Multiple contractsduring a recovery period from multiple successful knee surgeries.

3. BaxterHealthcare PlasmafractionationBiologics CMO Dec 2003 – June 2006
Sr. Manager II, Quality Laboratories LA CA
 Staff of approximately 45+ chemists and medical technologists. 6 direct, 24/7 support of on site mfg
and 7 US plasma collectionsites.
 Responsible forthe site quality laboratoriesincluding– laboratory quality assurance,raw materials, in
processand finishedgoods analysis, technicalservices samples, validation, method development,
stability, regulatory compliance, etc.
 ReceivedSix Sigma/DMAIC Green Belttraining forLaboratory cycletime reductionprojects and overall
increased operational efficiency.
 Reduced operating by 0.5 MM overthe course of one yeardue toimplementation of continuous
improvement projectsand staff training in 6 sigma, 5S, lean lab, etc.
 Hosted and supported monthly audits by US and foreigncustomers, 3 FDA audits, and various
international regulatory bodies.
Lonza Biologics Proteins / mAB’s – Biologics CMO / API’s June2002to Dec2003
Assoc. Director of Quality Laboratories Portsmouth NH
 Staff of 70+ employees (analysts, supervisors and managers – 7 direct reports).
 Responsible forMicrobiologicsand Immunology laboratories, laboratory Quality Assurance and
regulatory compliance, raw materials group, Quality Control lab, analyticalmethods dev/Biochemistry,
TechnicalIS(LIMS)andEMlaboratory programs(undercGMP) compliance(cGMP/GLP/GTP,ICH,etc).
 Supported site wideand directedlaboratory organizationalculturechange ie. Continuous quality
improvementbroughtto the mfg floor.Employeesempoweredandengaged (TQM,Lean,etc.).
 One of sevenSite Directorsplanning and implementing strategic initiativessupporting positive
culturalgrowthatthePortsmouthNHsitesupportinga 460+ employeemammaliancellculture
manufacturing facility.
 Managed a successful relocationproject of all Quality Laboratories from 4500 sq.ft.to17,000 sq.ft,
includinga LIMSdeployment,whileconcurrently providingseamlessmanufacturingsupport, comingin
3MM under budget and requiring no additionalhead count.
 Reducedgroup operating costby 25% in 10 months due to successfulimplementationof continuous
quality improvementinitiatives. Leftduring a company downsizing.
GenzymeDiagnostics mAB’sandtesting -MedicalDevice June 2001 to June 2002
Quality Control Manager SanCarlos,CA
 Responsible fora group of 10 in QC, QA, Customer Service, Laboratory Safety and TechService.
 Laboratory regulatory complianceoperating under 21CFR210/211 and 800’s, ICH Q7A.
 Facility closureannounced; receivedand acceptedjob offerfromLonza.
DSM Catalytica Small MoleculeAPI’s CMO June1999to June2001
Quality Control Manager Palo Alto CA
 Managed eight to twelve24/7professionalchemists and supervisorsin QC laboratory assuring an audit
ready operation, regulatory and quality assurance compliance (ICH Q7A GMP’s, CFR 210/211).
 Implemented SPC/SQC program forin process adjustments, raw material evaluations, specifications.
 Responsible for laboratory QA, Safety, IS, regulatory and QC operations.
 Remained for last batch during a facility closure after purchase by DSM and started immediately with
Genzyme.

4. --Non-cGMPindustrialexperience—
GE Power&Water,Trevose, PA Specialty Chemicals June1993to June1999
Research Scientist / Supervisor– Corp. R&D, ProductSupport(1997 – 1999)
Senior Scientist– Corp. R&D, ProductSupport (1995 – 1997)
Scientist– Corp. R&D, ProductSupport (1993 – 1995)
 Managed corporatetechnicalservices, raw materials and product support QC functions. Responsible for
productquality at Beaumont, TX Manufacturing facility andprimary US Quality contactfor3
international satellite laboratories supporting manufacturing (WidnesUK, Helsingborg Sweden and
Qualiano Italy) assuring product quality harmonization and ISO Quality Assurance compliance.
 Member of an internationaltechnicaltransferteam representing corporatequality control.Includedscale
up support frombenchto pilotthen transfer to site. Implementationof analytical/QCtestingmethods,
transferprotocolsand SOP harmonizationforGlobalfacilities.
 Responsible forinvestigation and disposition of productquality incidentsforglobal raw materials,
manufacturedand purchasedpolymers and globally manufacturedreaction products.
 Corporate member of ISO9000/14000 role out team; Schooledin and utilized TQM/leanfor process
improvements prior and during role out.
 Development, use, transfer and training of analyticalmethods used to support R&D and Mfg.
 ProvidedQC testing and productsupport for Corporate R&DOrganic Synthesis, Raw material release,
PolymerChemists and Pilotfacilities.
Huls America FunctionalSilane monomers and siliconecure systems Sept1990to June1993
QC method development chemist
 QC analysis of functional silanes (TCS, etc) by GC, FTIR, NMR, GC-MS, etc.
 Methods development and QC of functional silicone fluids and elastomer cure systems- GCP, FTIR,
water analysis, AA, etc.
 Facility purchased by UCT.