Experience

Quality Consulting Group, LLC

• Puerto Rico
• Outsourcing and Offshoring Consulting
• 1 - 100 Employee

• Senior Quality Consultant

  • Feb 2023 - Present



The Janssen Pharmaceutical Companies of Johnson & Johnson

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr QA/QC Supervisor: : Quality Leader- Start-Up and Best Business of a Biotech Parenteral Site

  • Jul 2012 - Dec 2022

  During my years of experience, I have performed the following functions: • Lead regulatory compliance activities and helping to enforce quality assurance policies and best practices covering the safety, design, production facilities, equipment, materials, organization, processes, procedures and inspection during start-up project and best business routine manufacturing activities associated to Combination and Parenteral Biotech Manufacturing activities. • Manage and provide technical guidance in the oversite of Product, Method and Test transfer, Specifications revision, Validation lifecycle and production protocol design and execution, ensuring compliance with FDA and global regulations as well as emergent internal directives. • Support site Validation related activities for the design, commissioning, qualification, and continued Validation maintenance of all Equipment, Facilities, and Utilities, including identifying opportunities for improvement. • Manages and coordinates overall activities to execute Master Batch Records Certification (MBR/MES), Product Release, Process Audits and Quality Oversight to ensuring the conformance to cGMP and EU regulations. • Responsible to manage and ensure that the Documents Controls, Quality, Manufacturing, Laboratory and Complaints Investigations (Deviation / Non-Conformance), Root Cause Analysis, CAPA’s, Corrections, effectiveness check, Commitments and Change Controls (ETS TrackWise System) records are appropriately managed and documented in compliance with cGMPs, Company Global Standards and Company Policies. • Responsible to provide ongoing coaching and mentoring to assure that team's competency remains current with changes in regulatory and industry standards. • Manage budgets, planning and auditioning that relate to personnel management and QA and QC Parenteral areas. Show less



Amgen

• United States
• Biotechnology Research
• 700 & Above Employee

• FL Manufacturing Manager: Operations Leader- Best Business of a Parenteral

  • Feb 2011 - Jun 2012

  During my years of experience, I have performed the following functions: • Responsible for managing a large production area in a Biotechnology manufacturing production facility. • Responsible of conduct Manufacturing Investigations (Non-Conformance /Deviation), Root Cause Analysis, CAPA’s, Corrections, Commitments records (TrackWise System) and SOP’s related to Production process. • Provided operational guidance to production associates ensure process specifications are met and produced material meets quality expectations. • Manage and oversee the Manufacturing activities (Thawing, Formulation, Filling, Drying, Sealing and Packaging) associated with the manufacturing of Parenteral products, Aseptic Processing (Media Fills), Clean Room disinfection / Cleaning and Environmental Monitoring (EM) activities. • Lead continuous process and systems improvements for future production efforts. Work collaboratively with the other departments to ensure department and company objectives are achieved. • Manage budgets, planning and auditioning that relate to personnel management and production area. Show less



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Manufacturing and Aseptic Process Supervisor: Operations Leader- Parenteral Facility

  • Mar 2007 - Jun 2010

  During my years of experience, I have performed the following functions: • Manage and oversee the Manufacturing activities (Aseptic Processing, Formulation, Filling, Drying, Sealing, Controlled Classified (Clean Room) and CNC Areas Disinfection/ Cleaning, Environmental Monitoring (Viable/ Non-Viable) and Qualification, Visual Optical Inspection/Packaging) associated with the manufacturing of Parenteral products and Aseptic Processing (Media Fills) activities and enforce Aseptic techniques. • Ensure that production will be cost effective by estimating costs and negotiating and agreeing budgets. Lead continuous process and systems improvements for future production efforts. • Perform administrative duties, such as regular (daily or weekly) employee meetings, Inventory System (SAP), Kronos time keeping/attendance/vacation requests, performance appraisals, disciplinary actions, job descriptions, interviewing, rewards, recognition, training and development. • Lead continuous process and systems improvements for future production efforts. Work collaboratively with the other departments to ensure department and company objectives are achieved. • Responsible of conduct, review and approve Manufacturing Investigations (Non-Conformance/Deviation), Root Cause Analysis, CAPA’s, Corrections, Commitments records, Change Controls (ETS TrackWise System) and SOP’s related to Production process. Show less



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Operation Quality Consultant: Quality Expert on Oral Solid Dosage Facility

  • Feb 2006 - Feb 2007

  • During my years of experience, I have performed the following functions: • Responsibilities of develop and establish quality systems programs and plans that ensure compliance with the Quality System Regulations. • Evaluate the Oral Solid Dosage Manufacturing process and documents workflow (Dispensing, Dry-Mill, Compression, Coating and Bulk Packaging) to incorporate quality controls and reduce errors. Assisted in the development of procedures for consistency in the quality within the organization. • Responsible for the development and direction of procedures, methods, and systems associated with the control and GMP compliance of manufacturing operations. • Support manufacturing process, batch record review, cGMP record reviews, Non-Conformance, Complaint Investigations review, Corrective and Preventive Actions (CAPA’s) and Change Control using TrackWise System related to process. Provided the necessary coaching and mentoring to the Manufacturing and Quality Departments. • Provide training in Quality Process & Techniques to the Manufacturing and Quality Departments and suppliers. Show less



Pharmalucence

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Lead Production Technologist/ MIBG/ Radiopharmaceutical - Nuclear Pharma

  • Jan 2004 - Dec 2005

  During my years of experience, I have performed the following functions: • Lead the Production activities (radio chemical synthesis, filling, final sterilization, Visual Inspection/Packaging and Shipping) associated with the manufacturing of radioactive Parenteral products. Monitor the production processes and adjust schedules as needed. • Ensure that the production of the radioactive Parenteral Products will be cost effective by estimating costs and negotiating and agreeing budgets. • Provides contamination trends report and statistical analysis to accomplish internal manufacturing standards. Provide input and support to engineering and management for modifications and upgrades to the production equipment/systems. Show less