Consultant

  (610) 462-4090

  info@qualitysolutionsnow.com

Professional, bilingual consultant with sixteen years of experience in quality compliance, validation and infrastructure systems (Biotechnology, Vaccines and Pharmaceuticals). Broad experiences gained working for pharmaceutical, device and biologics manufacturers.  Background in validation oversight, technology transfer, regulatory documentation, change control procedures, and electronic document management/training systems (delivery and compliance tracking), supporting lyophilized products, injectibles, bacterial and viral vaccines, testosterone gels, small molecule API, solid and liquid formulations.

CORE COMPETENCIES

  • Pharmaceutical Sectors Supported: Small Molecule
  • API, Bacterial and Viral Vaccines, Monoclonal
  • Antibodies/Biotech/OTC (End to End Supply Chain)
  • API Product Development
  • Process Validations (IQ/OQ/PQ)
  • Validation Master Plan
  • Analytical Equipment Validations
  • BAS Qualification
  • Equipment Installation
  • Cleaning and SIP Validation
  • Requalification (Validation Maintenance)
  • Guidelines and Procedures Development
  • Facilities and Utilities Validation
  • Filter Integrity Testing and Validation
  • CCI Validation
  • Regulatory Filings for Bacterial Vaccines
  • Annual Review
  • Product Complaint Investigations
  • Adverse Events Reporting and Investigation
  • Regulatory Agency Inspection Support (EMA, FDA, Health Canada)
  • Consent Decree Management Operations
  • Remediation (Work Plan Implementation)
  • Project Management/Facilitation
  • Statistical Analysis Techniques
  • CAPA Systems (Track Wise)
  • Document Management Systems Administration
  • Training Delivery Systems Administration
  • System Development Life Cycle (SDLC)
  • Risk Management, Analysis and Assessments
  • User Acceptance Testing
  • Document Management Systems
  • Training Tracking and Delivery Systems
  • Training Development and Delivery

SELECTED ACCOMPLISHMENTS

  • Established collaboration with Local Site PMO (LN, LP) and Home Office PMO to facilitate timely completion of consent decree regulatory commitments for Validation Master Plan, Cleaning Validation, Process Validation, Packaging Validation and Computer System Validation CD work plan steps.
  • Provided direct manufacturing site support to ensure consent decree work-plan steps are ready with appropriate documented evidence of execution for company level, corporate level and third party expert confirmations and verifications.
  • Managed CSV and Non-CSV validation interdependencies with manufacturing and facilities QSEs (Quality System Elements).
  • Facilitated the identification and management of interrelated activities to enable the successful completion of Validation Master Plan, Cleaning Validation, Process, Packaging and Computer System Validation procedural and remediation steps.
  • Lead receipt, triage, investigation and tracking of product complaints and assessment for potential recalls.
  • Managed investigations and ensured commitments were delivered by expected deadlines.
  • Managed all facility and related validations associated with Biopharmaceutical Manufacturing facility and related cGMP operations, including:
    • Focused on cleaning validation (assessment and development), utilities, process/facilities equipment, and computer systems and cleaning processes (CIP and COP) using risk assessment methodology.
    • Provided management and oversight of in-house and contracted resources for overall facility startup activities.
    • Provided technical and risk assessment support used in the change management process.
  • Created, implemented and maintained a validation maintenance program for supply chain, biotechnology process, QC Microbiology laboratories, and QC Chemistry laboratories equipment and facilities.
  • Reported progress by implementing quarterly metrics on compliance to scheduled assessments (the implementation of this program enabled the EMA approval of a biologic product).
  • Led design, development, and delivery of education and training solutions in support of Local and Market Level initiatives, including:
    • Ensured that personnel learning expectations around the manufacturing floor operations were met, including performance evaluations and Site Level SOP training.
    • Partnered with business clients and quality organizations to improve human performance and promote compliance.
  • Supported procedural documentation deliverables to organization both internally and globally, leveraging best practices throughout company.
    • Managed Functional Area Representatives (super users) and system improvements by developing user performance, periodic review, and productivity metrics.
    • Reviewed and approved of Change Requests related to a document management system.
  • Lead implementation of quality metrics and communication strategy for use of PharmaDoc (documented periodic review performance was enhanced considerably after implementation).
  • Collaborated with cross-pharma sectors to deliver training (US and Europe) to new super users and facilitate new company on-boarding into the system.
  • Served as member of Quality Validation Harmonization initiative.
    • Lead update, format, and completion of approval cycle for worldwide validation guidance documents.
    • Authored technical guidelines to standardize validation practices among manufacturing sites.
  • Provided technical guidance by developing applications, laboratory scale studies for cleaning and sterilization cycle validation, preparation of protocols, execution of studies, and by issuing the appropriate documentation in order to support atypical investigation and new process implementation, recall management and investigations (management and training of Jr. Engineers).
  • Managed process improvement projects and conducted experiments for filter validation and container closure integrity (CCI) [outcome of experiments used to investigate product packaging issues, to justify CCI combinations (vial, stopper, tubing, sealers) and to identify potential sources of contamination for culture media and bulk vaccine manufacturing processes].
  • Led execution of requalification studies and investigations for cleaning validation and sterilization cycle performance as scheduled (responsible for completion of protocols, final reports and technical memos, and validation documentation revision as part of Bulk Bacterial Vaccine manufacturing facility Pre-approval Inspection).
  • Collaborated in product change over activities for Bulk Manufacturing campaigns (API).
  • Conducted batch record documentation review and collaborated in investigations related to manufacturing issues ultimately used to make determinations for product release or disposition.
  • Implemented Inter-Empleo Computer Software for Department of Labor Employment Services, including:
    • Worked in development and testing of application.
    • Led training development and delivery during new application rollout at client.

PROFESSIONAL EXPERIENCE

  • System One LLC, Liaison for Validation and Process Development (McNeil, Fort Washington, PA) – Dec 2012 to Sep 2014
  • Auxilium Pharmaceuticals, Corporate Compliance Specialist IV (Horsham, PA) – May 2012 to Dec 2012
  • Auxilium Pharmaceuticals, Senior Validation Associate (Horsham, PA) – Nov 2009 to May 2012
  • Merck & Company, Senior Learning Specialist (West Point, PA) – Jan 2009 to Nov 2009
  • Johnson & Johnson, Centocor R&D Senior Specialist Training and Procedural Documentation (Wayne, PA) – Jan 2007 to Jan 2009
  • Johnson &Johnson, Global Biologics Supply Chain, LLC, Validation Engineer II Worldwide Validation Services (Horsham PA) – Aug 2004 to Jan 2007
  • Merck & Company, Senior Engineer Bio/Sterile Validation (West Point, PA) – Jan 2003 to Aug 2004
  • Merck & Company, Staff Engineer Bio/Sterile Validation (West Point, PA) – Mar 2001 to Dec 2002
  • Merck Sharp & Dohme, Engineer Technical Operations (Barceloneta, PR, USA) – Jul 1998 to Mar 2001
  • Deloitte & Touche Consulting Group, Systems Analyst (Hato Rey, PR, USA) – Jan 1998 to Jul 1998

EDUCATION

  • Bachelor of Science, Major in Chemical Engineering, University of Puerto Rico – 1998

TRAINING

  • Passed Engineer in Training (EIT) Exam
  • Risk Management Methodology
  • Principle Centered Leadership
  • Project Management
  • ANOVA (Comparison of Means)
  • Understanding Human Error
  • Planning for Supervisors
  • Building High Performance Teams, Peer Influence
  • Analytical Problem Solving
  • Separation and Purification Techniques
  • Basic Microbiology
  • Container Closure Integrity: Dye Ingress Testing, Headspace (Vials)
  • PRoVOX, Fisher Scientific
  • Safety and Environmental training