Remote Data Entry Specialist with 20+ Years QA Experience

SUMMARY OF QUALIFICATIONS: Over ** years of experience in the regulated industry. Areas of expertise: SOP Design/Improvements, Technical Writing, Quality Systems Management (e.g. Investigations/CAPAs, Change Control, Complaints), Investigation Process/Root Cause Analysis, Auditing/Assessment of records (investigation/CAPA, procedures, validation documents, plans, etc.), systems, facilities, Data Integrity/ALCOA principles Analytical Laboratory systems/records, Remediation, Quality Improvement Plans, Process Analytical Technology (PAT), Gap Assessments, Coaching/Mentoring, Training Tools Design & Delivery, Post Marketing Surveillance, 483 Response Development/Writing, Translation, etc.

Types of Industry: Pharmaceutical, Medical Device, Natural Health Product, Sterile Injectable/Aseptic, API Manufacturing

Languages: Bilingual: English/Spanish/Basic French

International Experience: Puerto Rico, USA (NJ, California, Kentucky, West Virginia, Florida, Nebraska, Minnesota, Maryland), France, Singapore, Spain, Canada, Colombia

EXPERIENCE

VIATRIS, Indore, India (Remote) Business Excellence Consulting (BEC) 08/2025 – 01-2026

Support Investigations/CAPA Quality System. Prospective review of current laboratory and manufacturing investigations. Oversee investigation documentation and ensure adequacy of the investigation through coaching/guiding investigators throughout the process. Generate reports with outcome of investigation assessments. Make final recommendations for approval of investigation reports.

MYLAN, Nashik, India (Remote) Business Excellence Consulting (BEC) 09/2024 – 12/2024

Evaluation of the adequacy of the investigation system by performing a retrospective review of closed laboratory and manufacturing investigations. Generate an assessment report of findings, gaps observed, recommendations for improvement, identification of regulatory concerns, etc. for each investigation reviewed. Participation in the development of final report to be submitted to the site leadership by providing a holistic summary of findings and recommendation for all investigations assessed.

CATALENT, Baltimore, MD ProQuality Network 04/2024 – 08/2024

Investigators Team Leader – Lead, develop, coach, mentor investigators team. Oversee manufacturing process investigations (Gene Therapy), ensure quality of investigations, oversee team’s overall performance, review/approve investigations, participate in Quality Metrics, process improvement, escalations, etc.

LABORATORIOS ABBOTT, Cali, Colombia Business Excellence Consulting (BEC) 04/2023 – 07/2023

Quality Consultant – Assessment of adequacy of Quality Systems (CAPAs, Change Control, Complaints, Annual Product Review) to ensure alignment and compliance with company corporate policies/FDA requirements and INVIMA requirements. Deliveries included documentation of gaps identified, presenting findings to site leader in charge, proposing recommendations for improvements and actively supporting the implementation of corrective actions including updating standard operating procedures, reparation of Training materials (e.g., Change Control System), and knowledge transfer to colleagues.

Creation of new document Finished Products Manual of Defects – Cali products, etc.

AUROLIFE, NJ, US & Laboratorios Normon, Madrid, Spain Business Excellence Consulting (BEC) 07/2020 – 02/2022

Quality Systems Expert - Supporting remediation activities to ensure compliance with FDA requirements through an assessment of the adequacy of their investigation system (AuroLife and Normon). The scope included the development of checklists for the assessment of the investigation documents, and for the invalidation of laboratory results, evaluation of retrospective and prospective laboratory/manufacturing investigations for pharmaceutical oral solid dosage form and aseptic products, review and final “go ahead”/approval for ongoing investigations, technical writing, SOP improvements, data analysis/charts creation, coaching personnel on investigation process, proposing recommendations for improvement and supporting their implementation, as applicable.

Quality Expert. Assessment of Stability Program FDA 483 observations for Normon Laboratories to ensure compliance with FDA requirements, for aseptic product, in collaboration to FDA 483 response writing. Worked directly with Normon’s team for the development of FDA 483 response in support of FDA pre-approval inspection, CAPAs proposal to address gaps, support technical writing and translation, etc.

NATURES’S BOUNTY, Winnipeg, Canada Reliant Life Sciences 02/2020 – 03/2020

Quality Assurance Manager: Team Management: about 20 people. Management of Deviation Investigations system, Batch Record Review team, Deviations team, Packaging QA Inspection Operations. Approval of company GMP documents: validation, qualification, calibration, SOPs, Change Control, deviations, among other responsibilities.

ERCROS, Madrid, Spain Business Excellence Consulting (BEC) 10/2019 – 01/2020

Quality Expert: Assessment of Laboratory records, Laboratory Controls, ALCOA and Data Integrity practices to ensure compliance with FDA requirements, in preparation for FDA inspection/approval of API products for the US market. Some of the activities included ensuring reference standards used for API laboratory testing met USP requirements, ensure compliance with product/test specifications and ensuring quality and accuracy of reported laboratory results. Project deliveries included recommendations

proposal for gaps encountered.

INTEGRA, Plainsboro, New Jersey Business Excellence Consulting (BEC 08/2019 – 09/2019

Quality Expert: Regulatory Affairs Support: Gather, review and complete documentation related to Post Marketing Surveillance (PMS), which included Complaints, PMS Plans, Periodic Safety Update Reports, FMEAs, Medical Device Reports (MDRs), among others.

MYLAN, Morgantown, West Virginia Business Excellence Consulting (BEC) 06/2019 – 08/2019

Third Party Independent Review - Auditing internally previously performed gap assessments for Foreign Residue Investigations on marketed product(s) to ensure quality of marketed product and compliance with FDA requirements. Reporting outcome of gaps and proposing corrective actions to address findings.

NATURE’S BOUNTY, Winnipeg, Canada Reliant Life Sciences 10/2018 – 04/2019

Investigations Consultant – Pharmaceutical/Natural Health Products – Remediation Project

Assessment of Deviation Investigation System & deviations electronic system (SOLABS) for compliance with ALCOA principles, data integrity, alignment with required process, and compliance with Health Canada regulations. Proposed improvement recommendations and ensured timely implementation (e.g., Implementation of enhancements to applicable SOPs, developing work Instructions for Deviation Investigation System, updating access controls procedure/process to electronic system to ensure a higher level of compliance including traceability, data integrity, etc.)

Assessment of Training Program, improvement proposal and implementation (e.g., developing training module for lead investigators and its implementation)

Mentoring/Coaching Lead Investigator(s)

Cleared Deviation Investigations backlog by 100% (over 300 hundred documents) (team effort)

PIRAMAL PHARMA SOLUTIONS, Kentucky, US Oxford Global Resources 06/2018 – 08/2018

Technical Writer – Investigations – Sterile Injectable Products - Deviation Investigation Writing – Batch Record Review

BBRAUN, Irvine, CA, US Mentor Technical Group 10/2017 – 04/2018

CAPA Investigations / Quality Consultant - Medical Device/Aseptic Product - Remediation Project – Assessment of open CAPAs and investigation records in support to Validation activities of aseptic serum bags. Ensuring validation activities were successfully completed, CAPAs/Verification of Effectiveness completed and writing final report encompassing all investigation and validation steps and activities completed in support of investigations closure.

Technical Writing, - CAPA Closure / Change Control – Batch Record Review.

SMITH’S MEDICAL, MN, US Business Excellence Consultant 10/2016 – 07/2017

CAPA Consultant – Medical Device - Quality Improvement Plan – Technical Writing

Assessment of investigation records in support of implementation of improvements to their CAPA/Investigations System, and to ensure compliance with FDA requirements and company procedures. As part of the implementation of improvements, was responsible for five (5) global sites (i.e., Check Republic, Italy, Australia, Japan, China) with timely CAPA review, coaching training and investigation closure and approval. As part of the implementation activities, it included coaching site CAPA Owners /Coordinators & review investigation reports for closure readiness for site CAPA Board approval.

Liaison between sites and Central Team for issue escalation and resolution

JOHNSON & JOHNSON, Guaynabo, PR PR Professionals 08/2016 – 10/2016

Quality Manager – Pharmaceutical products

Assist Quality Director in support of global regulatory and quality compliance activities.

Communications with sites for data gathering, Data Reporting & Issue escalation and resolution.

SOP Revision/Technical Writing

ZIMMER/BIOMET, Ponce, PR Conde Indu Services 03/2014 – 09/2015

Quality Engineer - Remediation project - Quality Support of Validation/Re-Validation activities

Assessment of validation records for compliance with FDA requirements (e.g., 21CFR 820, focused on Production and Process Controls), gaps identification and determination of required remediation activities. As part of the implementation activities, acted as one of the Quality Representatives supporting design, review and approval of Qualification documents (IQ, OQ, PQ, DoE protocols prior to and after execution, deviation investigations).

Executed Validation Batch Record Review.

PREVIOUS EXPERIENCE

Sr. Quality Consultant - Pfizer, Guayama, PR - Conde Indu Services - Materials Certification Management / Supplier Evaluation, alignment of site SOPS with corporate standards

Sr. PAT & Compliance Scientist Consultant - Janssen, Gurabo, PR – Conde Indu Services – PAT Implementation Quality Support, Project Plan development, SOP Writing/Development, etc

SOP Translatior/Technical Writer (English/Spanish) - Mylan, Caguas, PR - PRISM-A Consultants

Quality Manager - Medtronic, Juncos, PR – Weil Group, Inc. – Quality Improvement Plan– Assessment of Change Control System to ensure alignment with FDA requirements (e.g. 21CFR 820, focused on Quality System Requirements), identify gaps and propose improvements. Implementation of improvements included Procedures Improvement Updates, Harmonization of procedures across 3 sites, training development and delivery on improved site procedures and harmonized procedures.

Implementation of electronic system (Agile) for Change Control. Quality Representative in charge of overseeing the development of the change process from a paper system to an electronic system. Collaboration/working together with different departments across sites to agree on implementation proposals, which included development of new procedures for all sites, Kepner Tregoe Investigation process, incorporation of Validation activities as part of the change control program for the sites, Training Design/Delivery to all 3 sites, continuous coaching for employee support post- implementation.

Quality Consultant PAT - BMS, Humacao, PR – PHDS Corporation – Development of SOPs and protocols for PAT implementation – Support Qualification activities of analytical instruments – Training Design/Delivery

Compliance Consultant - Lilly del Caribe, Guayama, PR – PHDS Corporation – Quality Systems – Management of site Quality Plan / CAPA system – Assessment of site procedures for compliance with corporate policies and standards, proposal of improvements and support of implementation of actions. Acted as the Quality Representative for the development of implementation activities of an electronic system for issuance, tracking and maintenance of validation protocols. Responsible for SOP writing, Training Design & Delivery.

Compliance Consultant - Wyeth Pharmaceuticals/Pfizer – PHDS Corporation – PAT Implementation Quality Support, SOP writing/delivery

Compliance Consultant - GSK, Cidra, PR – Pharmedia Compliance Consulting –– Technical Writing: Deviation Investigations, SOP translation/Writing, internal audits

Chemistry Professor - Columbia College, Yauco, PR – Organic and Inorganic Chemistry Professor Theory and Laboratory Courses

Quality Manager (QA, Global Stability Program, Analytical Laboratory), QA & Laboratory Supervisor, Analytical Chemist Pfizer - (New Jersey, USA – Paris, FR – Vega Baja, PR) – Laboratory Investigations (Writing, Review, Approval), Coaching/Mentoring, Analytical Method Transfer, Training Design/Delivery, Data Review, SOP writing/delivery. Performed Internal Audits - On site: Microbiology/Analytical Laboratories, Stability Program, facilities and Across sites to ensure compliance with site procedures and FDA standards/requirements. Global Manufacturing Compliance project – scope included auditing global site procedures for selected products to ensure alignment and compliance with registered/regulatory documentation filed in applicable Health Agency(ies). As part of Global Quality Support initiative, performed audits across sites (Singapore (i.e. Investigation system, laboratory records and controls, GDPs), Nebraska (e.g., focused on Buildings and Facilities), France (in support of FDA Inspection readiness, focused on Buildings and Facilities), Puerto Rico in support of laboratory method transfer system, among others).

EDUCATION

M.A Psychology (Organizational Behavior) Fairleigh Dickinson University, NJ, USA

B.S. Chemistry & 1 year Chemistry Graduate School University of PR - Río Piedras, PR

CERTIFICATIONS

Licensed Chemist (PR)

CAPA Management

Food Safety Management

Wine & Spirit Education Trust (WSET) Level 2

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