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|
From January 2023 to Current • 1 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
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
Review and approve deviations, change controls and/or CAPAs, as needed.
Negotiate Quality Agreements with new Clients.
Participate in Client audits.
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|
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
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 Rotateqฎ
Work with Deviation Management Team to implement corrective and preventive actions (CAPAs)
Quality Assurance Associate II|
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)|
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|
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