Quality Supply Chain

Tara Jordan-McKinney

linkedin.com/in/tara-jordan-mckinney115 • East Brunswick, NJ 08816 • 732-***-**** • **********@*****.***

Quality Assurance/R&D

Process Improvements • Manufacturing & Discovery • Diverse Products & Services

Seasoned, ambitious manager that leads and coordinates complex operations to maintain and improve product development/launches and manufacturing processes. Intuitive and skilled leader with business acumen and broad-based expertise, spanning quality assurance, process improvement initiatives, supply chain management, and product lifecycle management. Exemplary communication skills and excels in demanding, fast-paced environments. Core competencies, include:

Strategic Planning & Implementation

Quality System

Global Compliance & Regulations

Research & Development

Risk Assessment/Management

SAP

Internal Auditing

Global Operations Analysis/Process Redesign

Contract Manufacturing

Problem Resolution

ISO//GCP/cGMP/GLP/(21 CFR 210 & 211 and 21 CFR Part 11)

Professional Experience

JM Quality Consulting, LLC Nov 2017-Present

Business Owner

JM Quality Consultants is a professional quality consulting firm offering a full line

of consulting, auditing, and training services to meet your needs for the public,

private and academic sectors.

Colgate-Palmolive Global Technology Center, Piscataway, NJ 2001 - Jan 2018

Global Quality Category leader, Personal Care (Jan 2017- Jan 2018)

Oversaw global and local Quality Systems relating to Personal Care Division, brands included Toms of Maine, Sanex, Protex, & Soft-soap. Responsibilities included Change Control (Emoc), Discrepancy Management, Corrective and Preventive Action, Training, Auditing, and Batch Release. Liaised with departments to ensure site operations compliance with corporate and agency requirements. Drive Global Continuous Improvement using Six Sigma and Risk Management to define and solve complex business problems

Ensured compliance and implementation of CP Quality Standards, Quality Systems, and adherence to cGMP’s globally.

Enhanced analysis of complex issues and succinctly summarized critical action to drive continuous improvement in Quality risk principles, maximizing quality/reliability to measure performance against establish standards and minimizing cost.

Interacted with Global Teams and support functions to verify Chemical, Biological, Manufacturing, and Control activities, aligned with Clinical, Non-Clinical, and Regulatory Affairs efforts in support of product development and launches globally.

Redefined product development process from local to global procedure, which included Personal Care, Oral Care, Toothbrush, and Home Care divisions.

Led 27 successful Quality Technical Agreements for Domestic and Global Fragrance Houses, Toms of Maine, Contact Manufacturing, and Personal Care.

Certified CP Auditor: Led ESM Audits of RM Suppliers, Contract Manufacturers, & Colgate Palmolive Facilities.

Partnered with Global Analytical & Global Microbiology on programs and procedures.

Reviewed global stability protocols, data, and reports for global regulatory submissions of registered products.

Ensured global adherence to the Raw Material Qualification SOP for Personal Care raw materials in FTG, Sustainability, and Grid Projects.

Tara Jordan McKinney Page Two

Supported and conducted site Training for cGMP, FDA, & Audit Readiness. Successful FDA audit in 2017.

Managed transition and removal of talc materials out of all personal care products by 4Q2017. Reviewed and approved mine reports globally and reports to senior management.

Provided Raw Material Qualification Program Management, including RSPS, Flavor and Fragrance, review, approval, backup for categories (OC & PC).

Partnered with Global Microbiology on programs and procedures that included C&S and water validation.

Explored new methodologies and applied quality management principles to drive more effective quality assurance conformance and process improvements

Sought to increase speed and lower costs to achieve product safety compliance which met consumers’ needs and quality requirements. Used analytics to reduce unnecessary testing; saved $20M.

Developed site wide training matrices for all categories and support functions.

Quality Tech Manager, Global Home Care Division (CCG, R&D, Contract Mfg., and Supply Chain ) - (2013-December 2016)

Employed comprehensive understanding of FDA, EPA, Dfe/Green Seal, and OSHA regulations to ensure compliance of plant and laboratory operations. Managed, tracked, and investigated global consumer complaints and recommended resolutions and improvement processes to R&D in the reformulating and stability profile of products.

Drove continuous improvement using six sigma approach for contract manufacturing by monitoring and reporting Quality KPI, MSI, Nonconformance’s, Mock Recalls, OOS, CAPA and Process Controls. Led global APR reviews for CP and Contract Manufacturing.

Launched Global Temperature Mapping Program (designed to measure the temperature of products stored in corrugate containers and transported in trailers across distribution network); significantly reduced recalls and saved over $3M per category.

Directed link between Contract Manufacturers and R&D on Quality related topics to ensure FDA/Regulatory Government compliance including monitoring quality metrics, performing annual risk assessment authoring, and executing CAPA.

Managed compliance activities such as management reviews, industry standards assessment, training, deviation and CAPA management, and change control contract mfg. and internally.

Developed and implemented standardized quality technical agreements for contract manufacturing and raw materials suppliers.

Strategically partnered with Supply Chain team to consolidate domestic and global contract manufacturing, resulting in company savings of $16.6M.

Established Global Kosher / Halal Program for cross-functional categories.

Successfully resolved on-going prop 65 and EPA issues and guaranteeing compliance.

Re-designed the consumer complaint process and documentation system for in-depth investigations by the CP and contract manufacturing plants.

Investigated and/or evaluated manufacturing and laboratory deviations or incidents as well as associated CAPAs. Providing direction and recommendations as to future course(s) of action. Successfully facilitated several prop 65 recoveries in North America with zero fines and no impact to the supply chain operation.

Strategically partnered with Supply Chain & R&D to reformulate industrial Fabuloso Brand; saved $20M.Spearheaded downsizing of Home Industrial Products and saved $5M internally and securing $200K in FTG savings from contact mfg.

Directs the resolution of complex quality issues during design and development and during design transfer.

Reviewed and approved all product releases for clinical and consumer panel/testing.’

Tara Jordan McKinney Page Three

Quality Specialist- (2011-2013)

Developed, implemented, and enforced aggressive KPI metrics in line with global targets. Oversaw, managed, and approved clinical studies for both product and formula claims. Standardized the global consumer complaints process.

Led execution of the annual mock recoveries for CP manufacturing and contract manufacturing.

Fostered and cultivated collaborative relationships with Colgate Palmolive to efficiently resolve customer and product issues.

Redesigned North American OSQ program for cross-category functions, as Regional Manager

Assured acceptable KRS reviewed and approved prior to releasing product from Colgate Palmolive and Contract Manufacturing plants.

Quality Leader Home Care Global Division (2010 – 2011)

Oversaw and managed technology transfer process at the Piscataway Technology Center as well as contracted manufacturers. Managed the six-stream process for global cross-category product releases. Meticulously reviewed and approved packaging validation and EMO projects. Reviewed stability protocols for FDA / EPA submission.

Led successful FDA/ EPA / Kosher readiness and inspection activities for Piscataway Tech Center and Cambridge Manufacturing facility.

Key Driver in transitioning Home Care Dish product from Triclosan to Lactic Acid that led non-FDA product to registered EPA product.

Led tech transfer transition of R&D North America to Mission Hills Mexico.

Led the FDA inspection of Home Care Cambridge Plant with zero findings.

Quality Supervisor General Product Management & Consumer Packaging (2007-2010)

Devised and developed quality training program on the validation protocols for pilot plant

equipment. Directly interfaced and supported marketing team’s implementation of new products

and product enhancements for consumer and clinical testing. Oversaw approval/rejection of

components specific to labeling, in-process materials, finished products, and production

records. Ensured transfer of technology by reviewing procedures and validation protocols and

approving/rejecting proposed processes.

Created and executed vendor procurement assessment method designed to identify appropriate technology-center calibration vendor, resulting in an FTG cost saving of $250,000.

Kept abreast of all R&D instrumentation developments to identify and recommend opportunities.

Developed cleaning and sanitization validation policy for pilot plant process equipment.

Spearheaded development of new R&D instrument and equipment laboratory layout.

Led Home FDA inspection with zero findings.

Led consecutive, successful EPA, Kosher, and Prop 65 inspections/investigations with zero findings.

Sr. Quality Assurance Specialist R&D Multiple Categories (2002-2007)

Devised, developed, and implemented internal audit system to support all North American categories. Trained all categories in the US Technology Center on FDA regulations, GMP best practices, and quality systems. Reviewed and approved clinical studies and designed raw material qualification guidelines for all categories. Managed the Global Oral Care Division Formulation System. Participated in developing key release specifications for oral, personal, and home care products.

Created a comprehensive quality systems template (for FDA, EPA, and kosher inspections) for R&D Technology Center.

Developed & Executed the first successful calibration/validation program to be in compliance with all government agencies.

Created and executed Corrective Action and Preventive Action (CAPA) Program including change control and deviation SOPs for North America technology centers.

Developed cross-category technical bundle book for all global product launches.

Implemented and managed $450,000 equipment validation/calibration program.

Led three consecutive successful FDA inspections with zero findings.

R&D Sr. Research Scientist Oral Care Validation (2001-2002)

Utilized GC/MS to establish and validate flavor profile for oral care products.

Researched unknown flavor compositions and levels for the next generation of toothpaste products.

Previous Employment

Research Scientist, Purdue BioPharma L.P., Princeton, NJ

R&D Analytical Chemist, Ortho-Clinical Diagnostic (Johnson & Johnson Company), Raritan, NJ

R&D Chemical Engineer, Merck Research Laboratories, Rahway, NJ

Education and Certifications

MBA, Management of Technology, New York Institute of Technology, New York, NY

BA, Chemistry, Rutgers State University, New Brunswick, NJ

Master Certificate in Applied Management, Villanova University, Radnor, PA

Six Sigma Green Belt, Institute of Industrial Engineers, NJ

Colgate-Palmolive Project Management Certification/ Dale Carnegie Leadership Training

Awards, Recognition, Affiliations

Guest Lecturer, Rutgers University Graduate Stem Program, Newark NJ, Dec 2016, 2017, 2018

Rutgers University LSAMP 2nd Annual Stem Fest Panel Speaker, Newark NJ, Nov 2017

Colgate-Palmolive You Can Make a Difference Award, 1Q 2016 Nomination

Colgate-Palmolive technology Excellence Award, 1Q 2016 Nomination

Certified Lead Colgate-Palmolive Lead Auditor, 2011-2017

Member, American Society of Quality/American Association of Quality, 2004-2015

Guest Lecturer, Rutgers University of New Jersey, New Brunswick, NJ, 2003-2006/2013

ASQ Minorities in Quality Chair, 2008-2009

ASQ Fall Gathering Conference Design Team Coordinator/Lector, 2007

Colgate-Palmolive Quality Professional Award, 2006

Manchester Who's Who Among Executive Professional Women, 2004, 2005

Empire Who's Who of Empowering Executive Professionals Executives, 2004, 2005

Colgate-Palmolive Stockholders Award, 2004

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