I am a Quality Professional with over 20 years experience in the pharmaceutical industry (Manufacturing and Biotech). I possess experience in contract manufacturing, vaccines and biologics, clinical supplies and packaging, and External Manufacturing.
Clinical Project Lead Specialist|
Resilience, Inc.
From January 2023 to Current • 3 year(s)
Clinical Project Lead Specialist
• Work collaboratively with internal stakeholders and as necessary external partners/vendors to
execute within a world-class GMP Quality Program.
• Build strong relationships and collaborate closely with Clients as well as internally with the
CMC/Operations/Development teams.
• Participate in all Client meetings and provide updates to Quality management.
• Be the lead for Quality on Client activities and communications.
• Organize and manage scheduling Client visits and audits, as needed.
• Provide oversight over all Client change requests and providing all client notifications for quality
records.
• Review and approve deviations, change controls and/or CAPAs, as needed.
• Negotiate Quality Agreements with new Clients.
• Participate in Client audits.
Quality Analyst|
Johnson & Johnson, Inc.
From November 2021 to January 2023 • 2 year(s)
• Supports EMQA Quality Leads and Quality Account Managers through various projects and quality/compliance improvement activities in EMQA
• Represents EMQA on projects and improvement teams to guide quality/compliance requirements
• Supports batch record review and batch disposition of US Self Care drug products from external manufacturing and packaging sites
• Supports the processing of retain samples from external packaging sites
• Supports the distribution and tracking of implementation of analytical methods and specifications at EM sites
• Supports the tracking of microbiological samples and results from external contract laboratories
Senior Quality Specialist, CMO Quality Management|
Sanofi, Inc.
From October 2014 to November 2021 • 7 year(s)
• Responsible for direct to patient activities for Gene and Cell Therapy projects
• Coordinate review and approval of Master and Executed Batch Records
• Collaborate with Packaging group to identify and investigate Deviations and customer complaints; helps drive Corrective and Preventative Actions (CAPAs) as appropriate
• Provide Quality insight during Project Management meetings
• Present data during Site Quality Council meetings
• Responsible for performance of Quality Risk/Impact assessments of vendors and suppliers
• Performs external audits of potential and existing Suppliers
• Provides oversight of Vendor Audit Program
• Manages Supplier Management System for the site
• Performs release of Investigational Medicinal Products and components
• Manage the Quality Technical Agreements to ensure new agreements are written and approved before new critical vendors or contractors are utilized
Quality Specialist|
Merck & Co., Inc.
From August 2010 to October 2014 • 4 year(s)
• Provide support directly to the production floor via batch record and logbook audits, provides coaching and mentoring of manufacturing supervisors and operators completing documentation
• Coordinate with production to discuss, resolve, and eliminate documentation observations
• Ensure compliance with internal, FDA, and other regulatory agency requirements
• Actively participate in the Tier process and uses this forum to escalate concerns and best practices
• Perform Quality review of new and updated Site Master Formulas
• Update and review Standard Operating Procedures (SOPs)
• Participate in aseptic process simulations for Rotateq®
• Work with Deviation Management Team to implement corrective and preventive actions (CAPAs)
Quality Assurance Associate II|
Eisai Inc.
From September 2008 to August 2010 • 2 year(s)
• Initiate complaint investigations and communicate directly with doctors and staff regarding adverse events
• Successfully completed Annual Product Review of medical device for review and approval
• Initiate investigations, perform root cause analysis, and determine corrective/preventive actions (CAPAs)
• Review completed Investigations and Deviations for potential impact on batch record documents
• Audit manufacturing records and related documents for completeness and accuracy
• Initiate actions as required to correct/complete batch records and/or related documents, dispositions all batch records
Quality Assurance Associate (Contractor, Aerotek Scientific)|
Lonza, Inc.
From April 2008 to September 2008 • 0 year(s)
• Review batch records for adherence to company policies and GMPs
• Organize files and filing systems, Maintain GMP training systems
• Verify/review accuracy of databases, logbooks, and spreadsheets
• Notify supervisors of any variants to review of batch record, issuance, or non-conforming incidents
Quality Assurance Associate II|
AppTec, Inc.
From October 2005 to April 2008 • 3 year(s)
• Review/approve Testing, Manufacturing and Product Development batch records
• Review and approve deviations, investigations, and Out of Spec occurrences
• Review Validation and In-process reports
• Inspect steps in cell banking, virology, and analytical chemistry lab studies
It's my pleasure to have you join, us as a new or
seasoned member. May you have an amazing,
blessed and marvelous day
Tagged by
Ralph White on 09/07/2023
