Summary
Work History
Education
Skills
Professional Development And Certifications
Languages
Work Preference
Timeline
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Open To Work

MELISSA K. WATKINS

Chicago,IL

Summary

Award-winning, and growth strategist offering a comprehensive record of success in promoting quality manufacturing and production processes through delivering hands-on leadership in creating, implementing, interpreting, and executing quality management and food safety systems in compliance with corporate policies and regulatory requirements. Change driver responsible for managing technical risk analysis, report generation, customer communication, investigations and the execution of corrective and preventive actions and plans. Interpret regulatory authority/standard regulations, guidelines, and procedures and facilitate their implementation. Partner with stakeholders, teams, and management in the establishment of methods, techniques, and criteria for projects and programs while ensuring budgets and schedules exceed objectives.

Work History

Director of Quality, Food Safety & Regulatory (QFSR)

Farmer’s Fridge
04.2022 - Current
  • Responsible for scaling best in class food safety and quality programs through a period of rapid growth.
  • Reports to the COO.
  • Subject matter expert on behalf of the organization for quality, food safety, and regulatory compliance issues.
  • Build, develop, and scale a team that is data driven and results oriented with an appreciation of internal and external customers needs.
  • Set challenging metrics and performance expectations for regulatory compliance, microbiological performance, and HACCP programs and hold team accountable.
  • Provide tools, training and opportunities for everyone in the company to understand and champion quality and food safety culture.
  • Lead, implement, and validate the effectiveness of food safety, quality, and sanitation policies, standards, and SOPs in compliance with FSMA and USDA regulations, as well as SQF code.
  • Final escalation point for food safety decisions, including recall management, with support of CEO.
  • Ensure effective and efficient follow up, corrective actions and consumer responses for product complaints.
  • Manage budgets for scale and hold teams accountable in partnership with operations leaders.
  • Approve all product labeling and marketing materials to ensure compliance with regulatory requirements.
  • Ensure readiness for, and manage all 3rd party, customer, or regulatory audits and coordinate all necessary communications with FDA, USDA, State, local regulators and other agencies as necessary.

Senior Manager Quality & Food Safety (QFS)

Vital Proteins
10.2020 - 03.2022
  • Ensure high-quality products are delivered on time and within budget.
  • Manage all the systems, processes, and initiatives that alleviate quality issues.
  • Quality management and compliance accountability for internal manufacturing, as well as external co-manufacturing locations – primarily leading quality approval, managing non-conformances and releasing product.
  • Lead the technical quality accountability for an upcoming $40M building expansion capital project.
  • Grow, lead and mentor a quality and food safety team to support the development of a talent pipeline for Q&FS including internal and co-manufacturer quality.
  • Implement and ensure ability to deliver against KPIs within the Quality Organization.
  • Drive continuous improvement and ensure alignment with broader Corporate Quality KPIs.
  • Act as the backup for the VP of Quality and Food Safety.

Regional Quality Manager

GEA Farm Technologies
03.2019 - 10.2020
  • Coordinate and oversee the Quality Assurance program in all NAM/LAM Hygiene sites.
  • Lead Spanish speaking multi-site quality team providing direction for standardized quality systems across all sites (US, Mexico, Argentina, Uruguay, Colombia, Chile).
  • Auditing and (re)certification of co-manufacturing sites, including managing validation programs.
  • Complete programs focused on drug product compliance with US-FDA (21 CFR 210 & 211); Health Canada (GUI-0001 & GUI-0012); Japan (MAFF); and various other countries’ GMP standards.
  • Manage and lead: QA teams; Quality Management System development and management; and Quality Control laboratories.
  • Responsible person and primary contact for regulatory bodies (US-FDA, Health Canada, etc.).
  • System owner of the ISO 9001:2015 compliance across all GEA Farm Technologies Hygiene Sites.
  • Quality Management and other statistical analysis tools, including FMEA, Gage R&R, DOE, and SPC.
  • Create and manage training and development programs; Risk assessments.

Analytical Operations Leader

The Dow Chemical Company
01.2017 - 01.2019
  • Report to the Site Production Leader while also leading and overseeing a large and diverse workforce.
  • Executed the Site Analytical Strategy as well as improved and leveraged analytical resources, including technology, people, and equipment.
  • Accomplished in establishing a people-centric performance culture, steered optimal cost-competitiveness of analytical services, and orchestrated continual laboratory improvement in compliance with all 21 CFR 210, 211, and 820 requirements.
  • Navigated across several teams to implement strategic initiatives to promote project progress for 6 laboratory moves and ensure maximized client satisfaction in the end.
  • Designed strategic training plans and providing appropriate resources for successful execution in partnership with relevant stakeholders and leadership teams both within and across departments.
  • (Formerly Dow Corning/Hemlock Semiconductor)

Quality Engineering Manager / Quality Engineer III

The Dow Chemical Company
01.2010 - 01.2017
  • Compliance and Regulatory Quality and Auditing; Customer, Supplier and FDA Audits; cGMP implementation and procedures, CAPA and verification of effectiveness, 21 CFR 210/211 & 21 CFR 820, ISO 9001, ANSI, HACCP (Food Safety & Quality), as well as microbiology and stability testing and programs.
  • Responsible person and primary contact for regulatory bodies (US-FDA, Health Canada, etc.).
  • Achieved a drastic reduction in RDH mixer’s batch time by 18%, increased process improvement by 90% as well as generated multi-million-dollar cost savings through executing Six Sigma Projects focused on decreasing specific impurities in polysilicon.
  • Orchestrated an overall 5% reduction in energy usage while playing significant roles in implementing a Six Sigma project geared towards reducing power consumption rate in certain CVD reactors.
  • Acknowledged for exceeding corporate expectations in coordinating business, site, and plant/department quality programs designed to drive the business towards accomplishing profitability objectives in alignment with customer and product regulatory requirements related to the quality management system.
  • Accepted the Dow Corning Manufacturing and Engineering Excellence Award for expertise in Six Sigma, Process Engineering, and Manufacturing agility that enabled the HIMS to capitalize on critical customer need for the new product launch.
  • (Formerly Dow Corning/Hemlock Semiconductor)

Technical Support Team Leader

Yoplait - General Mills
01.2009 - 01.2010
  • Managed maintenance operations and plan plant downtimes while reporting directly to the Site Manager.
  • Ensure Food Safety compliance via site HACCP plan, SSOPs and GMP.
  • Led successful startup of new blow-mold filler/packer line including IQ, OQ & PQ validations.
  • Leveraged expertise in coordinating training and development programs tailored to employee growth needs.
  • Collaborated with teams and stakeholders in the initiation of multiple continuous improvement initiatives.
  • Streamlined technical support functions through proficiency in operating equipment such as case packers, high-speed fillers, HVAC, and FANUC robots.

Group Manager / Training Coordinator

Anheuser-Busch, Inc.
01.2003 - 01.2008
  • Facilitated strategic improvements to optimize the lautering process, resulting in an annual cost savings of approximately $1M.
  • Ensure SQF Food Safety compliance via HACCP, SSOPs and GMP.
  • Increased the efficiency and accuracy of the inline instrumentation and launched an improved beer-release planning system that helped achieve a maximum decrease in packaging lines’ downtime.
  • Performed as the Area Manager role for both the Brewhouse & Fermenting and the Chips & Finishing facilities.
  • Obtained the Brewmaster’s Special Recognition Award for benchmarking accomplishments in 2004, 2005, 2006, and 2007.

Education

Post-Graduate Program - Data Science & Business Analytics

University of Texas McCombs School of Business
09.2022

Bachelor of Science - Chemical Engineering

Michigan State University
East Lansing, MI
05.2003

Skills

  • Six Sigma Black Belt
  • GMP & ISO
  • 21 CFR 111, 117, 210, 211 & 820
  • Quality Management Systems
  • Certified Lead ISO 9001:2015 Auditor
  • Continuous Process Improvement
  • Project & Program Management
  • Regulatory Compliance
  • Team Leadership
  • Product Development Support
  • Technical Support & Troubleshooting
  • Strategic Planning & Execution
  • Business Analytical Strategy
  • Analytical Instrument Validation & Qualification
  • Multi-Site Management
  • Process & Product Validation
  • HACCP
  • PCQI
  • Quality management systems
  • Quality metrics development
  • Supplier quality management
  • Strategic Planning & Execution
  • Business Analytical Strategy
  • Analytical Instrument Validation & Qualification

Professional Development And Certifications

  • Preventive Controls Qualified Individual (FSMA PCQI), 05/2022, Present
  • ASQ Manager of Quality/Organizational Excellence Certification CMQ/OE
  • ISO 9001:2015 QMS Auditor / Lead Auditor, Lloyd’s Register LRQA, 11/2018, Present
  • Black Belt, Six Sigma, Dow Corning Corporation, 07/2011, Present
  • American Society of Quality (ASQ), Member, 01/2011, Present

Languages

Spanish
Full Professional

Work Preference

Work Type

Full TimeContract Work

Location Preference

RemoteHybrid

Timeline

Director of Quality, Food Safety & Regulatory (QFSR)

Farmer’s Fridge
04.2022 - Current

Senior Manager Quality & Food Safety (QFS)

Vital Proteins
10.2020 - 03.2022

Regional Quality Manager

GEA Farm Technologies
03.2019 - 10.2020

Analytical Operations Leader

The Dow Chemical Company
01.2017 - 01.2019

Quality Engineering Manager / Quality Engineer III

The Dow Chemical Company
01.2010 - 01.2017

Technical Support Team Leader

Yoplait - General Mills
01.2009 - 01.2010

Group Manager / Training Coordinator

Anheuser-Busch, Inc.
01.2003 - 01.2008

Post-Graduate Program - Data Science & Business Analytics

University of Texas McCombs School of Business

Bachelor of Science - Chemical Engineering

Michigan State University