Summary
Overview
Work History
Education
Skills
Training
KEY QUALIFICATIONS
KEY INITIATIVES
Timeline
Generic

NICOLE HULEC

North Olmsted,OH

Summary

Experienced with quality management systems, ensuring adherence to industry standards and regulations. Utilizes problem-solving skills to identify and address quality issues promptly. Strong understanding of process optimization techniques to enhance product consistency and reliability.

Overview

19
19
years of professional experience

Work History

Lead Quality Specialist

Magellan Federal
06.2024 - Current
  • Develop, implement and manage Magellan Federal’s ISO9001 Quality Management System:
  • Align QMS objectives with the organization's goals, such as improving customer satisfaction, operational efficiency, or compliance.
  • Collaborate with Senior Leadership on Performance Metrics Development
  • Ensure leadership understands the importance of quality and allocates resources for the QMS.
  • Conduct internal audits: Regularly review processes to ensure compliance with QMS requirements.
  • Address non-conformities and root causes identified through audits or feedback.
  • Embed quality as a core value in the organization.
  • Served as the primary quality representative, providing guidance and support to Magellan Federal employees during the successful ISO 9001:2015 recertification audit and ensured adherence to quality management standards by facilitating audit preparation, resolving potential compliance issues, and promoting a culture of continuous improvement.

Vendor Quality Specialist II

Charles River Labs
09.2022 - 03.2024
  • Collaborated with subject matter experts and stakeholders to develop the global vendor quality team onboarding program and provided training and support to global vendor quality teams on best practices, procedures and business management software IQVIA SmartSolve(R) audit management module
  • Assessed and rewrote global vendor policy, global vendor management SOP and best practice documentation for the global vendor quality program
  • Team lead for the development of the global vendor contingency plan
  • Collaborated with stakeholders to establish quality agreements with vendors and multiple sites to ensure compliance with industry standards and Charles River Labs vendor quality management practices
  • Led data cleanup initiatives to enhance data accuracy, integrity and accessibility
  • Integral to the success of the version upgrade of SmartSolve(R) and migration to Azure, including writing and executing test scripts in real time, troubleshooting and collaborating with multifunctional groups to meet deadlines
  • Served as subject matter expert for the categorization, assessment, review and evaluation of Charles River Labs GMP vendors (manufacturers, distributors, contract testing and SaaS).

Senior Quality Assurance Associate, Site Lead- Supplier Quality, Site Lead- Change Control

MilliporeSigma
03.2017 - 07.2022
  • Managed change control program while continuously improving the program.
  • Provided monthly gap assessment reports to MilliporeSigma Life Sciences global supplier quality management team
  • Conducted biweekly raw material and component qualification meetings with supply chain, production, quality control and quality and led supplier qualification trouble-shooting efforts
  • Served as subject matter expert for supplier management at Cleveland site including primary resource during customer audits for all Supplier Quality Program questions and concerns
  • Managed multiple, high-priority quality initiatives while maintaining consistent flow through of the final product to customers.
  • Led investigations into non-conformances across production, packaging, shipping and receiving and quality control, and drove root cause analysis and corrective action implementation.
  • Advanced proficiency in SAP, TrackWise, ManGo (document management system)

Quality Coordinator for Personal Home and Health Care

Lubrizol Advanced Materials
11.2012 - 01.2017
  • Conducted monthly quality complaint metric report out and analysis meetings for both Personal and Home Care and Life Sciences businesses for product and platform management, sales, supply chain and quality leadership.
  • Gathered and analyzed data for key initiatives relative to continuous improvement, customer satisfaction, complaint trends, plant performance and audit activity.
  • Lead auditor for ISO9001:2008 audits at multiple plants and warehouses within Lubrizol Advanced Materials.
  • Developed and managed specification, audit observation and ISO9001:2015 Transition Team SharePoint databases.
  • Provided investigative support to Global Quality Manager for manufacturing deviations resulting in customer complaints or customer audit findings and coordinated investigative testing of products not meeting quality standards.
  • Coordinator for all Personal and Home Care and Pharmaceutical specifications and manufacturing authorizations.
  • Expert in document control management including change management documentation, audit and specification documentation and constructed multiple databases for improved maintenance of said documentation.
  • Advanced proficiency in Customer Response Management (CRM) database, SAP, EtQ Reliance, SharePoint and MS Office Suite 2013.

Laboratory Technician 4

Lubrizol Additives
11.2006 - 11.2012
  • Coordinated and conducted various tests to determine lead and copper corrosion, resistance to oxidation, viscosity, and extreme pressure capabilities of lubricating greases and oils following work procedures, ASTM standards and ISO guidelines
  • Maintained test procedures, control charts, test spreadsheets, ensured safety and good housekeeping, and adhered closely to RCRA, VPP and OSHA guidelines for waste disposal and good lab practices
  • Lead three-year study involving Lubrizol labs in Japan with the purpose of aligning test result analysis methods, which resulted in the resolution of discrepancies between testing locations.
  • Assisted in the development of multiple tests at the request of research and development and business segments within Lubrizol Additives
  • Responsible for annually reviewing documented procedures, work instructions, forms, and/or visual aids to insure compliance with ISO9001 standards.

Education

Bachelor of Science - Applied Quantitative Reasoning

Cleveland State University, Levin College of Urban Affairs

Bachelor of Science - Geological Sciences from College of Mathematical and Physical Sciences

The Ohio State University, School of Earth and Environmental Sciences

German language, history, and culture

Technical University of Dresden

Supplier Quality Professional Certification Course

American Society for Quality

Skills

  • Preventive actions
  • Customer satisfaction
  • Documentation control
  • Product inspection
  • Failure modes and effects analysis
  • Quality metrics
  • Quality management systems
  • Supplier quality
  • Corrective actions
  • Risk management
  • Internal audits
  • Quality system implementation

Training

Implementing Good Manufacturing Practices, Total Excipient Control to Ensure Patient Safety, Complaint Handling and Medical Device Reporting, EtQ Reliance Passport Beginner and Intermediate level user training, Introduction to LEAN, Project Management Skills, Cause Mapping, Responsible Care Management System, Failure Mode Analysis, and Risk Assessment Techniques.

KEY QUALIFICATIONS

  • Seasoned Quality Management Professional with 15 years of experience in ensuring compliance with industry standards and driving continuous improvement initiatives.
  • Extensive knowledge of Good Manufacturing Practices (GMP) regulations and guidelines, including CFR 21 Part 200-299 regulations and requirements, ISO 9001 and ISO/IEC 17025.
  • Skilled in collaborating with cross-functional teams and senior leadership to achieve organizational quality objectives.

KEY INITIATIVES

  • EtQ Reliance Electronic Quality Database Implementation Lead
  • Monitored team’s progress relative to established goal which included providing hands on support or guidance when necessary in addition to coordinating additional training and work sessions.
  • Regularly reported project status to stakeholders
  • Developed specification management module.
  • Customer Complaint Response Management Overhaul
  • Member of multifunctional task force assembled with the purpose of streamlining the customer response management process.
  • Conducted investigations into key areas within the existing process identified as roadblocks to success and reported findings back to the task force.
  • Supported follow-up training efforts at both corporate headquarters and manufacturing plants during implementation of the overhauled process.
  • Document Management and Information Retention Overhaul
  • Created SharePoint libraries to both house and protect all Personal and Home Care specifications, customer audit observations, and ISO9001:2015 Transition Team documentation.
  • Developed reference documentation containing descriptions of various plant processes for use by multiple business groups when responding to customer questionnaires and requests for information.

Timeline

Lead Quality Specialist

Magellan Federal
06.2024 - Current

Vendor Quality Specialist II

Charles River Labs
09.2022 - 03.2024

Senior Quality Assurance Associate, Site Lead- Supplier Quality, Site Lead- Change Control

MilliporeSigma
03.2017 - 07.2022

Quality Coordinator for Personal Home and Health Care

Lubrizol Advanced Materials
11.2012 - 01.2017

Laboratory Technician 4

Lubrizol Additives
11.2006 - 11.2012

Bachelor of Science - Geological Sciences from College of Mathematical and Physical Sciences

The Ohio State University, School of Earth and Environmental Sciences

German language, history, and culture

Technical University of Dresden

Supplier Quality Professional Certification Course

American Society for Quality

Bachelor of Science - Applied Quantitative Reasoning

Cleveland State University, Levin College of Urban Affairs

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