PROFESSIONAL SUMMARY

Experienced Quality Assurance professional in Pharmaceutical, Biotechnology, and Medical Devices industries. Working experience with regulations: 21 CFRs Parts 210, 211, 4, 11, and 820. Working knowledge in guidance documents: ISO 9001 and 13485, ICHs, and ISPE's GAMP 4.

SKILLS

CGMPs / GXPs

Document Control

Training Management

Project Management

Technical Writing

Process Improvement

Microsoft Office

Microsoft Project

VISIO

EXPERIENCE

Regulatory Inspection Specialist (contract)

Atlas Data Systems, LLC for MERCK Medical Research Laboratories IT, 7/2022 – 8/2023

Investigated historical changes of software system applications for FDA and EMA inspection readiness. Improved regulatory requests response time by compiling and creating a data bank of historical clinical trials' software systems releases. Tracked, and traced regulatory inspection requests and ensured its GxP compliance and timely submission. Maintained records of inspections conducted by government agencies. Helped create the roadmap of regulatory inspections playbook/strategy, for a consistent regulatory inspections’ response.

Documentation & Training Manager, Quality Systems

AVROBIO, Inc., 9/2021 – 4/2022

Trained and aided users routing GMP/CMC documents through VEEVA document management system. Performed document controller quality reviews for GXP documents. Ensured correct use of templates and formatting styles, per document type. Led cross-functional team meetings to create and/or review training role-based users’ curricula. Monitored document workflows and training requirements to ensure users' tasks completion in a timely fashion. VEEVA Business Admin and subject matter expert. Generated documentation and training metrics for quality management review meetings.

GXP Process Operations Center Process Facilitator, Manager (contract)

Lenox Executive Search LLC for Vertex, 7/2021 – 9/2021

Designed, developed, and maintained technical content deliverables to best meet users' needs, including process maps to explain complex information. Created and documented business processes and standard operating procedures. Led cross-functional team meetings, compiled information, and sought business process definition. Achievement: Information Mapping® Mastering Successful Policies and Procedures Certification.

Sr. QA Documentation & Training Specialist, Quality Systems

Romark, L.C., 4/2016 – 7/2021

Developed SOP mapping, identified gaps, and supported cGMP framework implementation. Created cGMP documentation templates (e.g., policies, SOPs, forms, and Batch Records among others). Authored procedures for Documentation Management, Training Management, Validation Documentation Management, and Logbook Management. Created cGMP training material and delivered classroom and/or web-based training for new hires. Implemented Job Description and Curriculum Vitae yearly process reviews and aligned Training Matrix requirements. Improved documentation and training processes by implementing MasterControl (MC) 11.2 and MC 11.6. Prepared curated training material, coordinated training sessions, and delivered companywide training to different audiences. Processed documentation and training tasks in MC and in TrackWise Digital (TWD).

Contributed with the requirements gathering (user stories) and design reviews for TWD change control, quality events & CAPAs, and audits (EQMS), document management (DMS), and training management (TMS) modules. Authored and executed change control data migration protocol. Participated in external warehouse and distribution supplier audit. Organized and led Change Control Review Board (CCRB) Meetings. Produced quality systems metrics for quality management reviews. Achievement: MasterControl® Configuration for Documentation & Training Modules Course Certification.

Quality Engineer, Sr.

Boston Scientific, 7/2013 – 2/2016

Initiated and completed manufacturing nonconformance investigations and drug stability program events. Closed Corrective and Preventive Actions (CAPAs) on time. Reviewed and approved drug product lot releases certificate of assurance (COAs). Reviewed drug product performance metrics trending and initiated quality events as needed. Improved process alerts by implementing out of trend (OOT)control limits, based on drug product's SPC historical data. Improved manufacturing operator’s re-certification program by updating defects’ inspection criteria and training material and provided training to personnel. Participated in annual product review report creation and approval. Generated training material for cGMP combination products and trained new hires. Conducted biennial SOP updates in Windchill. Supported business initiatives such as: manufacturing floor re-layouts, new product introductions, and regulatory submissions. Achievement: Obtained zero observations during external regulatory audit.

Project Manager (contract)

Pharma-Bio Serv for McNeil Consumer Healthcare, 7/2012 – 7/2013

Produced project schedules and tracked execution of key milestones communicating potential issues. Monitored teams’ daily activities execution, resources allocation and costs while identifying roadblocks and promptly find resolution to daily events. Promoted agility by fostering cross-functional teams' collaboration and effective on-time communication. Pursued efficient use of resources by identifying redundant activities. Consulted with project stakeholders throughout project to present updates, incorporate feedback and redirect concerns. Measured performance with appropriate project management tools and techniques. Managed project documentation and deliverables by version. Kept team members on track with regular in-person or remote meetings Achievement: Completed consent decree work plan commitments on-time for assigned functional areas of: Documentation, Training, Change Controls, Management Reviews, External Supplier Quality, Product Complaints, and Manufacturing Components.

Quality Engineer (contract)

Abbott Vascular, 1/2012 – 7/2012

Participated in guidewires manufacturing assembly line transfer project. Led topcoat solution method transfer for PR site. Supported new components qualification activities. Contributed to guidewires cost reduction project by creating quality metrics, identified yield top offenders’ root causes, and implemented corrective actions. Achievement: Spot Award for successful project completion of new assembly line transfer.

Quality Engineer

BARD, LTD, 3/2009 – 1/2012

Initially assigned as Document Control Supervisor with eight direct reports. Created documentation departmental metrics and tracked goals. Supported internal audit for CAPA System, monitored closure and effectiveness of actions. Tracked closure of both internal and external audits actions and provided support during regulatory inspection.

As Quality Engineer, investigated manufacturing nonconformances and customer complaints. Initiated Suppliers' Corrective Action Requests (SCARs) and monitored actions implementation. Supported suppliers’ certification program by evaluating performance and adjusting sampling plans, as needed. Evaluated Process Failure Modes Effect Analyses (PFMEAs) and updated as needed. Initiated CAPAs, developed investigations, implemented corrective and preventive actions, and performed effectiveness verifications within pre-established time limits.

Evaluated and approved manufacturing environmental monitoring investigations and equipment work orders. Trained personnel in visual standards, test methods, and inspection procedures. Produced and monitored quality metrics, evaluated trending, and implemented process improvement actions to prevent recurrence. Achievement: Successful CAPA completion related to field complaint resulted in zero instances after implementation.

EDUCATION

Master of Engineering Management (MEM)

Polytechnic University of Puerto Rico, San Juan, PR

Bachelor of Science in Industrial Engineering (BSIE)

Polytechnic University of Puerto Rico, San Juan, PR

CERTIFICATIONS AND TRAININGS

Project Management Professional Certification (PMP) Preparation Course

Train the Trainer Certification

Kepner-Tregoe Problem Solving Workshop Certificate of Completion

Six Sigma Green Belt Certification

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