Tracy Pedroni
Portland,OR
Summary
Quality Assurance and Regulatory Affairs professional with strong expertise in ensuring compliance and navigating complex regulatory landscapes. Known for effective team collaboration and delivering results, adaptable to changing needs. Skilled in regulatory submissions, risk management, and policy development. Valued for strategic thinking, clear communication, and reliability.
Overview
13
13
years of professional experience
6
6
Certification
Work History
Quality Assurance /Regulatory Affairs Manager
Good Clean Love, Inc.
01.2024 - Current
- Maintains all Quality System documents, updating and implementing quality systems as required
by applicable regulatory bodies and product development needs. - Maintains compliance with federal laws, including FDA inspections and serving as the touch point for all FDA activities.
- Implements, and manages processes to ensure that products meet required specifications for
quality, function, and reliability prior to delivery. - Identifies and analyzes issues, defects, and other problems, particularly when problems recur in
multiple products; recommends and facilitates solutions to these issues. - Works with governance committees to make and evaluate plans.
- Keeps abreast of evolving industry trends, allowing the company to adapt quickly to changes in the regulatory landscape.
- Performs and documents quality control checks to maintain compliance with company initiatives.
- Recommends, develops and makes improvements to processes.
- Prioritizes project-related tasks to efficiently complete essential tasks.
- Develops thorough internal audit findings areas of improvement, leading to strengthened internal controls.
- Collaborates with cross-functional teams to ensure alignment on regulatory requirements and timelines.
- Spearheads training initiatives for staff on Regulatory Affairs topics, and Quality System requirements, promoting a culture of continuous learning.
- Manages risk assessments and mitigations, resulting in a reduction of potential compliance issues.
- Oversees timely preparation and submission of high-quality documentation for product registrations and renewals.
- Successfully navigates complex legal regulations for various types of medical devices, cosmetics, and pharmaceutical products during their lifecycle.
- Develops strong relationships with key stakeholders, facilitating open communication channels between organizations.
- Actively participates in industry trainings and workshops, staying up-to-date on best practices in regulatory affairs management.
- Consults with regulatory representatives to manage filings, applications, and reports.
- Provides responses to regulatory agencies regarding product information or issues.
- Manages fees and applications, tracks product progress and handles all responses to regulatory inquiries.
- Reviews labeling, including any marketing materials (websites, social media, ads) for compliance
with Federal Regulations. - Identifies and analyzes issues, defects, and other problems, particularly when problems recur in
multiple products; recommends and facilitates solutions to these issues.
QA Manager
Panco Foods, Inc.
12.2021 - 11.2022
- Responsible for the overall development, implementation and upkeep of Panco Foods Inc.'s Food Safety Quality Management System
- Responsible for the overall program management, as well as ensured, through either delegation or direct action, the day-to-day implementation of food safety practices/processes and program adherence
- Led the continuous improvement and scaling of Panco Foods Inc.
- Food Safety Program maintenance in collaboration with Sr Managers, CEO/Founder, and other appropriate staff
- Updated, improved, and tracked all existing and new food safety requirements by the FDA, USDA, local and regional agencies
- Systematized documentation and ensured its completion, accuracy, and timeliness
- Served as the key contact for service contractors, and food safety and regulatory agencies
- Annual and New Hire training for Food Safety, SQF, GMP, Allergen and Food Defense requirements
- Sanitation Training to ensure employees understood the importance of and how to safeguard a clean, sanitary facility
- Trained employees to establish safety protocol- wearing the proper masks, non-slip shoes, aprons, and gloves to protect themselves and to ensure food safety
- Performed daily checks with team members in order to confirm they were complying with company policies requiring proper PPE (Personal Protective Equipment)
- GMP audits in relation to proper adherence of state and federal requirements
- Chemical safety - ensuring all hazardous chemicals are appropriately labeled and stored
- Led quarterly environmental testing for food safety
- Performed annual water testing
- Worked with appropriate teams to address issue(s) and establish processes and procedures
- Increased customer satisfaction with products by ensuring consistent quality across all platforms
- Promoted continuous learning within the QA department through regular workshops and trainings focused on evolving industry best practices.
- Implemented risk-based testing strategies that prioritized high-risk scenarios, enabling efficient use of resources during tight deadlines.
- Mentored junior team members, providing guidance and support to help them excel in their roles and contribute effectively to the organization.
- Managed cross-functional teams to ensure seamless coordination between QA, development, and support departments.
- Conducted root cause analysis on recurring defects, implementing corrective measures to prevent future occurrences.
- Collaborated with stakeholders to establish key performance indicators for the QA team, driving continuous improvement efforts throughout the organization.
- Improved overall efficiency of the QA department through strategic planning and resource allocation.
- Established a culture of collaboration within the QA department, fostering open communication channels among team members.
- Oversaw vendor relationships to ensure adherence to quality standards during outsourced projects or collaborations.
- Enhanced product quality by implementing rigorous testing procedures and protocols.
- Developed and implemented comprehensive quality assurance plans to monitor product quality and adherence to regulatory standards.
- Created and maintained quality management systems to align with industry standards.
- Conducted process and system audits to identify areas of improvement and enforce compliance with industry standards.
- Implemented new quality assurance and customer service standards.
Sr. Analyst, Food Safety & Quality
Del Monte Foods, Inc.
02.2015 - 07.2021
- Main contact for R&D, Sales, Marketing for QA customer compliance documentation
- Developed product specifications on new and existing products
- Assured QA compliance with customer documentation platforms for customers and suppliers
- Assisted with region sample grading during peak season
- In-plant record keeping review and approval in line with company specifications
- Assisted with internal audits as needed
- Developed and maintained QA database for Quality and Safety Documentation
- Maintained QA policies, procedures, formulas, and specifications on internal QA team site
- Mentored junior analysts, fostering professional development while enhancing overall team performance.
- Collaborated with cross-functional teams to identify areas of improvement, leading to increased operational effectiveness.
- Created dashboards to monitor and track key performance indicators.
- Developed customized reports, summarizing and presenting data in visually appealing format.
Assistant to Vice President of Innovation
Del Monte Foods, Inc.
08.2012 - 01.2014
- Provided superior daily support to VPs of Pet Snacks and Innovation corresponding teams
- Accountable for complex calendaring and scheduling with attention to detail
- Coordinated travel schedules for VPs and Directors of Pet Snacks and Innovation
- Scheduled meetings and conference calls for VPs, Directors, and Pet Snacks department
- Leadership of special projects requiring creativity and strong tactical execution
- Prepared and organized confidential information, reports and correspondence, and presentations
- Prepared expense reports, client billing, and managed invoices for Innovation Department & Pet Snacks
- Organized and maintained files for VPs of Pet Snacks & Innovation
- Follow-up on billing discrepancies in accordance with company protocol
- Organized, monitored, prepared, tracked and updated complex internal and external documents
- Scheduled personal appointments and engagements as needed
- Created complex Access databases for special projects thereby streamlining tracking process
Executive Assistant
Schiff Nutrition International
09.2011 - 07.2012
- Provided daily executive support to General Counsel, Chief Marketing Officer, and their corresponding teams
- Accountable for complex calendaring and scheduling
- Coordinated complex travel schedules for legal and marketing departments
- Scheduled meetings and conference calls for legal and marketing departments
- Prepared and organized confidential legal information, reports, and correspondence
- Updated and maintained continuing legal education and licensing requirements
- Prepared expense reports, client billing, and managed invoices for marketing and legal departments
- Organized and maintained billing files for outside counsel
- Followed up on billing discrepancies in accordance with attorneys
- Prepared complex marketing and legal decks on PowerPoint for board meetings
- Onboarded new hires as company continued to grow at a rapid pace
- Handled confidential and sensitive information with discretion and tact.
- Managed executive calendars, scheduling meetings and appointments and coordinating travel arrangements to optimize time.
- Served as a liaison between departments to facilitate effective communication throughout the company.
- Provided professional administrative support during board meetings, including agenda preparation and minute-taking duties.
- Supported executives in decision-making processes by conducting research and presenting findings in clear formats.
- Prepared and edited presentations on behalf of executives for both internal meetings and external conferences.
- Assisted in the development of company policies and procedures, contributing to a more organized work environment.
- Delivered exceptional organizational support enabling executive focus on high-level strategic initiatives fostering company growth.
- Contributed to budget management by monitoring expenses and providing detailed expenditure reports regularly.
- Proactively identified areas requiring attention or improvement aligning priorities effectively in line with executive preferences.
Education
Juris Doctorate - Law
Gonzaga University, School of Law
06-2004
BA - Political Science- Legal Studies/Pre-Law
California State University, Chico
06-2000
Skills
- Regulatory submissions
- Regulatory strategy
- Labeling compliance
- Regulatory intelligence
- Medical device regulations
- Regulatory policies
- Document management
- Risk management
- Audits
- ISO standards
- Report creation
- FDA interactions
- Pharmaceutical industry
- Premarket submissions
- License renewals
- License tracking databases
- Post-market surveillance
- Teamwork and collaboration
- Standard operating procedures
- Analytical thinking
- Training and development
- Audit oversight
- Quality control
- Quality assurance
- SOP development
Certification
- BRC (British Retail Consortium Quality Management System)
- SQF Practitioner Certification
- SQF Internal Audit Certification
- HACCP Certification
- Better Process Control School Certification
- PCQI (Process Control Certified Individual) Certification
- GMP Certification
- ISO 9001: Overview Certificate
- Recalls of Therapeutic Goods Certificate
- Medical Devices: Definitions & Lifecycle Certificate
- Ethics: Medical Devices
- Regulatory Professional Role Certificate
- Regulatory Affairs for Medical Devices Certificate (In Progress)
- Paralegal Certificate
Affiliations
- RAPS (Regulatory Affairs Professionals Society)
Timeline
Quality Assurance /Regulatory Affairs Manager
Good Clean Love, Inc.
01.2024 - Current
QA Manager
Panco Foods, Inc.
12.2021 - 11.2022
Sr. Analyst, Food Safety & Quality
Del Monte Foods, Inc.
02.2015 - 07.2021
Assistant to Vice President of Innovation
Del Monte Foods, Inc.
08.2012 - 01.2014
Executive Assistant
Schiff Nutrition International
09.2011 - 07.2012
- BRC (British Retail Consortium Quality Management System)
- SQF Practitioner Certification
- SQF Internal Audit Certification
- HACCP Certification
- Better Process Control School Certification
- PCQI (Process Control Certified Individual) Certification
- GMP Certification
- ISO 9001: Overview Certificate
- Recalls of Therapeutic Goods Certificate
- Medical Devices: Definitions & Lifecycle Certificate
- Ethics: Medical Devices
- Regulatory Professional Role Certificate
- Regulatory Affairs for Medical Devices Certificate (In Progress)
- Paralegal Certificate
Juris Doctorate - Law
Gonzaga University, School of Law
BA - Political Science- Legal Studies/Pre-Law
California State University, Chico
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