Microsoft Office, Excel, Access, Word, SharePoint, etc
Lisa Knowles
Chester,IL
Summary
Results-driven auditing professional with extensive experience in evaluating internal controls and risk management. Known for strong analytical skills and attention to detail, ensuring compliance with industry standards. Collaborative team member with focus on achieving organizational goals and adapting to dynamic environments.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Sr. Operations Quality Internal Auditor
Kindeva Drug Delivery
01.2022 - 03.2025
- Assisted in the preparation of audit reports that clearly communicated findings and recommendations to key stakeholders.
- Performed internal audits departmental operations, for compliance with documented processes, standard procedures and regulatory requirements.
- Produced audit reports.
- Contributed to a positive work environment by collaborating effectively with colleagues across all levels of the organization.
- Supported management in developing action plans to address identified issues, promoting timely resolution of audit findings.
- Prepared and distributed risk and audit reports to appropriate personnel.
- Provided valuable insights to management by presenting clear and concise audit findings, contributing to informed decision-making processes.
- Identified and reported audit issues.
- Investigated discrepancies discovered during auditing process.
Manufacturing Quality Assurance Specialist III
Pfizer Meridian Medical Technologies
10.2019 - 01.2022
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Ensured product compliance with industry regulations by staying up-to-date on relevant standards and guidelines, implementing necessary changes to maintain conformance.
- Mentored junior QA specialists, fostering a culture of continuous learning and professional growth.
- Optimized workflow efficiency by introducing automation tools into the QA process where appropriate.
- Ensure that product, processes, and materials are in conformance with quality standards,
customer requirements and compliance standards. - Perform monthly metrics, PowerPoint slides for the Management Department
- Developed SharePoint Website for Sites for better communications within different areas.
- Provided support for qualification, execution, and validation of new processes, products, and equipment to the manufacturing line.
- Auditing processes in the manufacturing process relating to formulation, filling, aseptic processes, inspection, assembly, labeling, packaging, and all testing for product release.
- Change Management action items improving and updating Certificate of Conformances, standard procedures, and job aids.
- Provide support for investigations by collecting and analysis of data, reporting information,
and following up on corrective action completion for quality compliance.
Manufacturing Quality Assurance Specialist II
Meridian Medical Technology Pfizer
02.2009 - 10.2019
- Final reviewer of batch records for military product
- Assist in reviewing and editing standard procedures and master records.
- Batch record reviews for releasing product.
- Ensure product, processes and materials are in conformance with quality standards,regulations, and customer requirements.
- Assisted with employee interviews for positions for auditors.
- Quality compliance walk throughs to review manufacturing processes to assist in GMP documentation for batch records.
Project Specialist
King Pharmaceuticals Meridian Medical Tech
08.2007 - 02.2009
- Writing, implementation, coordination of projects
- Supervisory role in completion of projects
- Problem solving/analysis.
- Cross functional investigations
- Trouble shooting OOS chemistry results.
- Laboratory formulations
- Pilot Studies with new products
- Extend expiry dates in product with DOE.
- Determine expiry date with new product.
- Stability Studies, Regression Analysis
Education
Bachelor of Science - Mathematics
Southern Illinois University, Carbondale
Carbondale, IL06-2004
Bachelor of Science - Chemistry
Southern Illinois University, Carbondale
Carbondale, IL12-1997
Associate of Science - Science
Southwestern Illinois College
Belleville, IL06-1984
Skills
- Detail-oriented
- Quality assurance
- Problem-solving skills
- Analytical thinking
- Decision-making
- Quality improvements
- Data analysis
- Issue resolution
Certification
• ASQ CQA Certification (Certified Quality Auditor)
• ASQ CQIA Certification (Certified Quality Improvement Associate)
• ASQ SSGB Certification (Six Sigma Green Belt)
Software
Minitab 16 Statistical Software
Outlook
RStudio
Microsoft VBA
Timeline
Sr. Operations Quality Internal Auditor
Kindeva Drug Delivery
01.2022 - 03.2025
Manufacturing Quality Assurance Specialist III
Pfizer Meridian Medical Technologies
10.2019 - 01.2022
Manufacturing Quality Assurance Specialist II
Meridian Medical Technology Pfizer
02.2009 - 10.2019
Project Specialist
King Pharmaceuticals Meridian Medical Tech
08.2007 - 02.2009
Bachelor of Science - Mathematics
Southern Illinois University, Carbondale
Bachelor of Science - Chemistry
Southern Illinois University, Carbondale
Associate of Science - Science
Southwestern Illinois College
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