Manager, Global Quality Systems Global Document Control and Translation

• Jan 2023 - Present

Senior Specialist Global Documentation Control and Training

• Jul 2021 - Jan 2023

Commercial Quality Assurance Specialist

• Jul 2019 - Apr 2021

Work as the Quality Lead liaison to affiliate sites and manage the medical device distributors in the Latin America and Canada regions for the Abbott Point of Care (APOC) division. Responsible for implementing and managing the Quality Management System for distributers and affiliates in the United States, Latin America and Canada. • Independently contribute to Quality System processes such as training, corrective action and preventive action (CAPA) activities, quality audits, and distributor/supplier qualification. • Created a new system for Distributor Qualification, which saved time when new distributors were being evaluated for onboarding. • Ensuring medical device distributors are reconciling complaints reporting. • Create and organize quarterly Regional Management Reviews by working with cross functionals teams to aggregate KPIs and trends for the region to present to upper management. • Serve as the Quality Lead and representative for the APOC division in the Latin America affiliate sites responsible for local Quality system document redlines, review and approvals per local regulations. • Quality Lead initiating and negotiating terms for Quality Agreements with distributors in the Latin America and United States sites. • Subject Matter Expert for the compliance of regional quality systems to ISO 9001/ISO 13485 standards. Regional quality representative for external agency audits.

Quality Assurance Specialist

• Oct 2018 - Jul 2019

Support the Quality Assurance department in facilitating the overall transition from a paper-based documentation system to Veeva QualDocs electronic documentation system for enhanced compliance, traceability and transparency. • Review CMO batch records for release of finished products into market for commercial distribution. • Author, revise and review written SOPs and submit changes as needed to meet GMP, corporate, and regulatory requirements. • Create, route, and track controlled records within the Veeva QualDocs System in an administrative role. • Facilitate the review of critical quality documents, such as Quality Agreements, Certificate of Analysis, stability data, protocols/reports, and CMO deviations and investigations. • Act as a liaison and interface with all major corporate facets to facilitate overall communications with internal and external stakeholders • Support CMOs in providing proper documentation in response to requests by global regulatory bodies, such as FDA, Health Canada, ANVISA, INVIMA, etc. • Expanded relationships with external CMOs to improve the process flow for closing investigations, CAPAs, and obtaining data for timely release of finished products. • Support project teams by participating in the resolution change management related issues and providing accurate and up-to-date information on status of a change.

Quality Assurance Specialist

• Oct 2017 - Oct 2018

Implemented new Corrective Action and Preventative Action process across multiple sites to align with current regulatory requirements. Navigated CAPA owners and department leaders through the new CAPA procedure with the aim of properly identifying root cause and implementing action plans that not only serve as corrective actions but promote continuous improvement. • Successfully transformed the Corrective Action and Preventative Action process across 4 USA sites to ensure compliane to FDA regulations and promoted a more audit readiness culture company-wide. • Supported Quality Management System activities by guiding the revision and implementation of the newly revised complaint process as part of FDA Warning Letter remediation activities. • Interact closely with Customer Service, Service, Repair, Regulatory Affairs and Sales to facilitate completion of implementation activities 50% of legacy CAPA in the first 60 days. • Evaluate all sources of incoming customer information, identify, investigate and document Customer Complaints, perform trend analysis and maintain all records to determine the Medical Device Reportability. • On site EtQ (quality and compliance management system) administrator for the Complaint and CAPA modules. • Responsible for providing data points for KPI to the Director of Quality Management Systems to assess progress of Quality Initiatives. • Provided backroom support for all internal, external, and customer audits.

Senior Corporate Quality Specialist

• Jun 2017 - Oct 2017

Ensure that the product quality complaint system is compliant, efficient, and sustainable by confirming that complaints are properly investigated, processed, and closed as per procedure and regulation. Act as a liaison between the customer and business unit to certify that proper customer relations are maintained and KPIs are being met.• Responsible for administration of the Product Complaint Management system to ensure compliance, effectiveness, and sustainability.• Utilize risk assessment to analyze from customer calls and inquiries regarding the quality, performance, or safety of products whether an adverse event needs to be designated.• Provide data trending information for dissemination to the Business Unit to maintain KPI’s for quality compliance and customer expectations.• Support company policies and procedures, goals and objectives, FDA regulations, and good manufacturing practices, while cultivating an environment of excellence when dealing with internal and external customer relations.• Participating member of the audit team in the role of lead auditor performing internal audits to assure regulatory compliance and help the company self-identify any gaps in the quality management system. • Review and ensure calls taken and data generated by junior staff is accurate and any escalations are brought to attention.

Corporate Quality Specialist

• Oct 2016 - Jun 2017

Accomplish day to day product complaint activities such as ensuring that complaints are processed and closed within the timeframe as required. As per compliance, maintain electronic and hard copy files of product complaint investigations and supporting documentation. • Handle incoming calls or inquiries from customers regarding the quality, performance or safety of products.• Utilize product and quality knowledge to provide the customer information that is relevant and helpful in addressing issues or concerns.• Review investigation results and prepare follow up letters to send to customers as needed. • Practice sound decision making that is in compliance with regulatory requirements as needed to close out pending complaint files. • Act as a liaison with other departments, divisions and organizations.• Serve as a back-up trainer for onboarding for new employees.• Participate in the company Internal Audit team.

Quality Control Microbiologist

• Apr 2015 - Oct 2016

Supported the Quality control department in performing finished product testing and stability testing to ensure that all products are not out of specification before being released into the market. Aided in performing machine cleaning studies to make sure that machines were properly sanitized.• Conducted corporate training for new hires upon request.• Execute training for production floor personnel on Micro Hygiene Awareness to educate on contamination control and cGMP policies. • Aide in and implement assessment creation for Micro Hygiene Awareness training.• Train Junior Microbiologists on microbiology test methods and lab procedures.• Review and audit data generated by junior microbiologists.• Creation of Training SOP for all microbiology laboratory personnel.• Ensure that the lab activities maintain compliance with current Good Manufacturing Procedures and Good Laboratory Practices requirements at all times.• Assisted in investigations, CAPAs, and provided quality improvement plans for recurring issues between laboratory and manufacturing floor. • Perform advanced microbiological testing on water, bulk pharmaceutical chemicals, drug products and components using rapid methods.• Investigate the growth, structure, development of microbial organisms on test products.• Well versed in rapid detection methods such as Celsis for detection and identification of bacteria and mold.

School Programs Coordinator

• Jan 2014 - Apr 2015

• Primary areas of responsibility include working with schools (K-12) and head starts (scheduling visits and book fairs, developing reading lists/curriculum creation) and assisting with the development of new initiatives. • Planed and directed efforts to involve students, families in bookstore programs and initiatives. • Developed curriculum for all ages (K-12, college, post-grad) tailored to educational needs • Established linkages with local schools to promote their involvement with La Casa Azul Bookstore • Represented the bookstore at community meetings and events/ interface with various community members. • Administered evaluations, attendance tracking, reports and documentation for educational programs/fairs. • Developed expertise on products, merchandising, and services in order to offer each customer the best guidance on conducting successful events.