Summary
Overview
Work History
Education
Skills
Websites
Certification
Timeline
Generic

Rachel Panico

Murfreesboro

Summary

Results-driven Quality Manager with over 30 years of experience leading teams to achieve operational excellence. Expertise in implementing strategic initiatives that significantly enhance productivity and efficiency across diverse environments. Proven track record in problem-solving and decision-making, ensuring high-quality standards and continuous improvement. Committed to fostering a culture of quality and collaboration to drive organizational success.

Overview

18
18
years of professional experience
1
1
Certification

Work History

Manager of QA, Quality Systems

HAEMONETICS
12.2014 - Current
  • Lead and oversee quality management activities across all North American distribution centers.
  • Lead, facilitate, and participate in a variety of audits, including ISO, FDA, OSHA, state, and corporate audits.
  • Conduct internal site, supplier, and clinical audits to ensure compliance and operational excellence.
  • Organize and facilitate Quarterly Quality Management Review meetings, providing actionable insights.
  • Manage and evaluate Non-Conforming Events (NCEs) from initiation through resolution.
  • Present NCE findings to the Medical Review Board, ensuring effective communication of issues and solutions.
  • Develop and implement Corrective and Preventive Actions (CAPAs) to address quality concerns and prevent recurrence.
  • Create, review, and interpret standard operating procedures (SOPs) and work instructions (WIs) for quality management processes.
  • Oversee product inspection and rework, ensuring compliance with quality standards and regulatory requirements.
  • Manage Quality Holds, ensuring timely resolution of issues to minimize operational disruptions.
  • Handle and resolve customer complaints, driving continuous improvement in customer satisfaction.
  • Track and analyze monthly quality data, providing insights into trends and areas for improvement.
  • Facilitate problem-solving meetings, utilizing root cause analysis, corrective actions, and effectiveness checks to resolve issues.
  • Conduct Final Quality Reviews, ensuring product quality and compliance before release.
  • Manage product certification documentation (COA, COC, COS) to meet customer requirements.
  • Provide support to third-party logistics (3PL) suppliers, addressing product release and quality concerns.

Regional Quality Associate II

American Red Cross
11.2007 - 12.2014
  • Directed communication and managed information submitted to the FDA regarding Blood Product Deviations.
  • Lead and participate in audits, including FDA, AABB, OSHA, state, and local audits, ensuring compliance with regulatory requirements.
  • Conduct thorough quality reviews and evaluations to identify and resolve problems impacting operations.
  • Present issues and findings to the Medical Review Board, ensuring clear communication and timely resolution.
  • Oversee and maintain Red Cross Licensure, ensuring compliance with applicable standards and regulations.
  • Interpret and enforce quality management and problem-solving procedures to address operational challenges.
  • Manage and report problem management activities to upper management, highlighting key issues and trends.
  • Handle and resolve customer concerns, ensuring prompt and effective action to maintain satisfaction.
  • Coordinate and communicate continuous updates of procedural changes from Biomedical Headquarters, as well as local procedural modifications.
  • Observe and report on collection staff activities, ensuring compliance with quality standards and operational guidelines.
  • Conduct and report findings from system audits to identify and correct areas of non-compliance.
  • Evaluate and analyze monthly tracking data (MSPR), providing a comprehensive report on trends and key issues in the Monthly Summary Problem Report to headquarters and the QI committee.
  • Participate in problem-solving meetings, leading Root Cause Analysis (RCA), corrective actions, effectiveness checks, and conducting Final Quality Reviews to ensure issue resolution.

Education

Bachelors of Healthcare Admin - Patient Safety & Quality

Southern New Hampshire University
05.2024

Diploma - undefined

Spruce Creek High School
05.1991

Skills

  • Quality Auditing: Extensive experience in conducting comprehensive audits to ensure compliance with industry standards
  • Quality Assurance: Proficient in establishing and maintaining robust quality assurance systems that meet regulatory requirements
  • Good Documentation Practices (GDP): Expertise in maintaining accurate, complete, and compliant documentation for all quality processes
  • Strong Presentation Skills: Capable of effectively conveying complex information to diverse stakeholders in clear and concise presentations
  • Analytical Thinking: Adept at analyzing data, identifying trends, and using insights to make informed decisions that drive continuous improvement
  • Quality Improvement Expertise: Dedicated to driving continuous process improvements to meet and exceed quality standards
  • Advanced Problem Solving: Skilled in identifying root causes and developing strategic solutions for complex operational challenges
  • Attention to Detail: Highly meticulous in ensuring precision, accuracy, and consistency in all aspects of work

Websites

Certification

  • Lean Six Sigma Yellow Belt
  • American Society of Quality - Certified Quality Auditor (Cert #68281)
  • Certified Florida Designated Pharmaceutical Representative

Timeline

Manager of QA, Quality Systems

HAEMONETICS
12.2014 - Current

Regional Quality Associate II

American Red Cross
11.2007 - 12.2014

Diploma - undefined

Spruce Creek High School

Bachelors of Healthcare Admin - Patient Safety & Quality

Southern New Hampshire University

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Rachel Panico