Summary
Overview
Work History
Education
Skills
Personal Information
Timeline
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Shireen Shaw

Sicklerville,New Jersey

Summary

Experienced quality manager and auditor with a strong focus on compliance, auditing, and management. Proven track record of leading client audits, internal audits, and managing regulatory inspections. Enhances operational efficiency through strategic corrective actions. Committed to mentoring teams and elevating quality standards to ensure regulatory compliance.

Overview

11
11
years of professional experience

Work History

Quality Assurance Auditor

QA Compliance
02.2023 - Current
  • Ability to work in a team environment and independently as required
  • Lead, host and/or Conduct site client audits, to present overall quality systems and procedures, and handle audit responses in a satisfactory and timely manner
  • Document audit observations in Master Control audit module
  • Drive closure of CAPA resulting from audits
  • Communicate with clients on compliance issues and corrective action surrounding PHL audits
  • Participate FDA, EMA, USDA regulatory and accreditation audits and inspections as directed
  • Conduct internal, external and vendor/supplier audits as directed by QA Management
  • Participate in the development of site and corporate compliance policies, procedures, and documents
  • Assume a contributing role in compliance projects and participate in corporate and site strategic meetings
  • Participate in training new hire to department
  • Host QP audits to determine regulatory compliance.

Quality Manager

Marken
01.2022 - 01.2023
  • Clinical Trials Distribution
  • Manage complaint and non-conformance handling, including CAPA management for two CTD Sites in North America
  • Hire, develop and mentor CTD QA Associates
  • Effectively interact with site and global Quality, Logistics, Operations, and stakeholders to maintain quality and help introduce new quality objectives
  • Internal audits of two CTD sites
  • Provide Quality oversight for validation/qualification of equipment, systems, and processes in accordance with regulatory requirements and Marken standards, policies and procedures
  • Author/collaborate with clients to ensure Quality Technical Agreements are in place
  • Internal/External audits
  • Face to face client interaction
  • SOP Development: Rewrites SOP's and work instructions to improve workflow
  • Develops processes to ensure Technical Documentation aligns with clients
  • Conduct client audits and regulatory audits including the FDA and the state of Pennsylvania
  • Managed staff
  • Worked with HR to determine actions related to employee retention.

Quality Manager

CSL Plasma
11.2019 - 12.2021
  • Chosen to lead root cause analysis of deviations and non-conforming results and implemented appropriate corrective and preventive actions throughout the product development process
  • Technical Documentation: Drafted technical documents such as deviation reports, testing protocol, and trend analyses
  • Efficiency Driven: Search for new ways to increase overall efficiency, utilize up-to-date technology, and improve quality
  • Quality Reviews: Scheduled and chaired quality review meetings to review the effectiveness of performance mitigating risk, improving throughput, and achieving customer satisfaction
  • Auditing Processes: Collaborated with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans
  • Client audits including FDA, GHA, EMA, CLIA and the state of Pennsylvania
  • Production Sampling Processes: Collected production samples regularly and performed detailed quality inspections
  • Oversaw the recruiting, hiring, and onboarding process by conducting interviews for a new establishment.

Quality Manager

American Red Cross
04.2013 - 03.2019
  • Manage Deviations: Completed deviation forms and recorded findings of the inspection process, collaborating with quality team members and department managers to implement procedural remedies
  • Managed Corrective Actions including root cause analysis while working with staff to improve overall quality
  • Internal Audits, Regulatory audits including FDA
  • Complaint Management: Created and collaborated in implementing a 1K+ complaint log, control plans, work and inspection instructions, local procedures, and visual aids and samples
  • Training Development: Built strategic training materials on quality improvement based on proven processes that have reduced complaints and improved efficiency.

Education

Master of Science - Management/Leadership

Strayer University-Global Region
03.2023

Bachelor of Arts - Business Administration/Management

Strayer University
06.2021

Skills

  • Quality Management
  • Quality Control
  • ISO Standards
  • Regulatory Compliance
  • Statistical Analysis
  • Lean Manufacturing
  • Auditing
  • Risk Management
  • Team Leadership
  • CAPA Management
  • Process Improvement
  • Continuous Improvement
  • Decision Making
  • Problem Solving
  • Data Analysis
  • Project Management
  • Communication
  • Critical Thinking
  • Quality Systems
  • GMP
  • GxP
  • Change Control Management
  • Quality Control Processes
  • ISO standards knowledge
  • Documentation Review
  • Quality Management Systems
  • Training and coaching
  • In-Process Inspection

Personal Information

Title: Quality Manager/Auditor

Timeline

Quality Assurance Auditor

QA Compliance
02.2023 - Current

Quality Manager

Marken
01.2022 - 01.2023

Quality Manager

CSL Plasma
11.2019 - 12.2021

Quality Manager

American Red Cross
04.2013 - 03.2019

Master of Science - Management/Leadership

Strayer University-Global Region

Bachelor of Arts - Business Administration/Management

Strayer University

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Shireen Shaw