Tracy Mazzola
Jackson,WI
Summary
Quality Manager with extensive experience, adept at enhancing quality management systems and ensuring regulatory compliance. Proven track record in CAPA and investigative analysis, coupled with strong team leadership skills. Successfully implemented process improvements that elevated product standards and fostered a culture of quality awareness across departments. Results-driven Quality Manager known for high productivity and efficiency in task completion. Specialize in process improvement, quality assurance protocols, and regulatory compliance.
Overview
24
24
years of professional experience
1
1
Certification
Work History
QUALITY MANAGER (Site Lead)
Addev Materials Healthcare
Menomonee Falls, WI
12.2024 - Current
- Facilitate staff training sessions on quality assurance best practices and procedures.
- Collaborate with cross-functional teams to identify process improvement opportunities and implement changes.
- Monitor production processes to ensure compliance with quality benchmarks and specifications.
- Enhance the Quality Management System (QMS) to improve product standards and ensure ISO 13485:2016 compliance.
- Establish effective communication channels between departments to promote quality awareness.
- Investigate customer complaints and developed resolution strategies and corrective actions.
- Conduct internal audits to identify areas for improvement and address non-conformities.
- Review and updated Standard Operating Procedures (SOPs) to align with evolving regulations.
- Manage the calibration and maintenance of quality testing equipment to ensure measurement accuracy.
- Facilitate change management processes, supporting the organization and stakeholders during program transitions.
- Develop internal audit plans to assess regulatory and standards compliance; prepared detailed audit reports for management review.
- Host customer and regulatory audits; managed audit responses and implemented corrective actions.
QUALITY OPERATIONS MANAGER
Sientra
Franklin, Wisconsin
02.2024 - 12.2024
- Lead Quality Operations team to ensure compliance with global regulations (FDA, ISO, Health Canada, Japan).
- Oversee CAPA, complaints, change controls, validation, and product release for in-house and contract manufacturing.
- Develop and train QA team members, implement process improvements to optimize efficiency and product quality.
- Maintain quality KPIs, reports, and dashboards to communicate operational performance to leadership.
- Manage Environmental Monitoring and Sterility Assurance programs.
QUALITY MANAGER/Sr. QA Engineer
Shine Technologies
Janesville, Wisconsin
06.2018 - 02.2024
- Maintained GMP-compliant Quality Management System to ensure product integrity.
- Managed Risk Register to identify and mitigate potential issues.
- Led customer and regulatory interactions, conducting complaint investigations and supplier qualification programs.
- Hired, trained, and developed QA personnel to enhance team capabilities.
- Oversaw equipment and measurement qualification and validation processes.
SR. COMPLIANCE SPECIALIST
Thermo Fisher Scientific
01.2017 - 06.2018
- Implemented 21 CFR Part 820/11 compliant quality systems for new medical devices.
- Conducted internal audits, validation reviews, and supplier assessments.
- Led root cause investigations, CAPA, and process improvement initiatives.
SR. COMPLIANCE AUDITOR
Catalent Pharma Solutions
04.2016 - 12.2016
- Managed internal, external, and supplier audits, including Health Authority Inspection preparations.
- Developed risk-based corrective actions and trained site personnel on Quality System compliance.
QA PRODUCT MANAGER / QUALITY ASSURANCE PRODUCT SPECIALIST
Catalent Pharma Solutions
09.2013 - 04.2016
- Served as primary QA liaison for client products, supporting audits, deviations, and change controls.
- Monitored key quality metrics and facilitated continuous improvement initiatives.
- Implemented corrective actions in response to quality failures or customer complaints.
- Led root cause analysis sessions to address recurring quality issues effectively.
- Reviewed and updated quality documentation to align with regulatory requirements regularly.
- Monitored product performance against customer specifications and standards, ensuring that all products met the required standards.
QUALITY ASSURANCE
Mylan
01.2002 - 09.2013
- Managed deviations, CAPA, investigations, batch record review, and recalls.
- Conducted Annual Product Reviews.
- Developed training materials for staff on quality control procedures.
- Collaborated with teams to assess and improve product quality.
- Implemented corrective actions based on quality assessment findings.
- Conducted Supplier Qualification Audits.
- Inspected incoming materials for quality and compliance with specifications.
- Conducted routine audits of production processes to ensure adherence to standards.
- Trained new employees on quality control procedures and best practices.
Education
Master of Arts - Organizational Leadership
Judson University
Illinois01-2013
Bachelor of Arts - Management & Leadership
Judson College
Illinois01-2007
Associate of Applied Science - Quality Engineering
Rock Valley College
Rockford, IL01-2002
Skills
- Regulatory compliance and audits (FDA, ISO, Health Canada, MHRA, TGA)
- Quality management systems (Trackwise, MasterControl, ComplianceWire, ACE)
- Corrective and preventive actions (CAPA)
- Deviation management
- Investigative analysis
- Change control processes
- Supplier qualification and management
- Team leadership
- Training and development programs
- Product release and validation oversight
- Risk management strategies
- Environmental monitoring practices
- ERP and QMS systems: SAP, NetSuite, DocuSign
Certification
- 2021 Annual GXP Course, FASTrain
- 2018 Practical Process Improvement, Ed Zunich
- 2013 Effective Investigation and Corrective Actions, Globepharm Consulting
- 2012 GMP Compliance & Auditing for Sterile Pharmaceuticals and cGMP Interpretation and Applications, Globepharm Consulting
- 2011 Lean Methods Accelerator, MoreSteam University
- 2010 GMP Compliance Auditing, PharmaNet
- 2010 Preventive Action, Compliance Online
- 2009 First Annual CAPA Congress, FDA News
- 2007 Designing and Delivering Training Programs, Employers Association Workplace Learning Solutions
- 2007 Conducting Bullet Proof CAPA Investigations, FDA News
- 2007 Conducting Annual Product Reviews, PTI International
- 2006 Corrective and Preventative Action Systems, FDA News
Timeline
QUALITY MANAGER (Site Lead)
Addev Materials Healthcare
12.2024 - Current
QUALITY OPERATIONS MANAGER
Sientra
02.2024 - 12.2024
QUALITY MANAGER/Sr. QA Engineer
Shine Technologies
06.2018 - 02.2024
SR. COMPLIANCE SPECIALIST
Thermo Fisher Scientific
01.2017 - 06.2018
SR. COMPLIANCE AUDITOR
Catalent Pharma Solutions
04.2016 - 12.2016
QA PRODUCT MANAGER / QUALITY ASSURANCE PRODUCT SPECIALIST
Catalent Pharma Solutions
09.2013 - 04.2016
QUALITY ASSURANCE
Mylan
01.2002 - 09.2013
Master of Arts - Organizational Leadership
Judson University
Bachelor of Arts - Management & Leadership
Judson College
Associate of Applied Science - Quality Engineering
Rock Valley College