Pharmaceutical compliance, Document Control, Pharmaceutical samples
Resume:
Mary V. Pearson
Elkins Park, PA *****
************@*****.***
linkedin.com/in/mary-v-pearson-a9441016
Professional Summary:
Pharmaceutical professional with direct compliance, document control and quality assurance experience all related to FDA and PDMA requirements. Monetarily rewarded for creating reporting that resulted in a two million dollar savings on sample spend at GSK. Investigating new opportunities where past experience can be added to new career experiences successfully. Open to investigating new opportunities outside of pharmaceutical industry where compliance, document control and quality skills will assist in and enhance ability to perform job functions.
Professional Experience:
Teva Pharmaceuticals: West Chester, PA March 2016 – February 2018
Technical Document Analyst II/ QA Auditor - Contract
Review and release Clinical Trial Batch Records
Review and Close out of Trackwise Change Controls due to implementation of Trackwise harmonized system
Release Label Log review
Review and entry of Batch Record detail onto QA Department Excel tracking spreadsheet
QA document vault organization
McNeil Consumer Healthcare Fort Washington, PA August – September 2015
Document Specialist II – Contract
Review, database entry, preparation of final consent decree documents for archival at Iron Mountain
University of Pennsylvania -Clinical Vaccine Production Facility (CVPF): Phila, PA Jan -July 2014
QA/QS Record Management Analyst - Contract
Review and organize records within a clinical trial environment
Record all files on department Excel spreadsheet
Prepare reports as requested by department Directors and map file location based on available space for ease of retrieval
Catalent Pharma Solutions: Philadelphia, PA – January – October 2013
Quality Assurance Document Control Analyst/Quality Assurance Archivist - Contract
Review and approve pre and post production batch records to ensure conformance with requirements of GMP and clinical trial protocol and appropriate GMP, review of material status, protocol conformance, clinical design layout, ensuring blinding techniques are followed, Monitor schedule for production priorities. Confirm proper randomization schedule utilization for correct patient treatment group assignment, Primary liaison with client for batch release
Ensure timely release of batch for protocol initiation date, release batch within scheduling database
Release batch within JDE inventory management system
Archive batch documents onto shared drive and within archive room
Review, archival of documents: including pack slips, batch records and documents received from other locations (post merger)
Trained QADC staff on archiving functions and assisted multiple departments with retrieval of documents from Iron Mountain
Supervised material handlers in preparation for retrieval of documents by Iron Mountain
Johnson & Johnson–Janssen Pharmaceutical: Titusville, NJ – September 2011 – March 2012
Sample Management group-Sample Compliance Analyst – Contract
Performed high level review of discrepant sample inventory reconciliations in order to insure that all processes have been properly followed and all sales representative sample inventories have been fully reviewed prior to reporting variance that is above the company established variance threshold to FDA
Trained administrative assistants in Iron Mountain Record Retention processes and assisted when needed
Johnson & Johnson; Spring House, PA September 2010 – May 2011
Document Control Group-Document analyst - Contract
Maintain central, controlled supply of classified and unclassified documents originating within J & J
Review documents to determine established classification level
Document data entry into J&J’s GREATS System
Ensured proper migration of irreplaceable data files
Work in a diverse and more complex environment including scientific customers and executives
Word processing, spreadsheet, database applications
Previous Experience:
Care First; Berwick, PA 2008 - 2009
Pharmacy Technician
Geisinger Medical Center; Bloomsburg, PA 2007
Information Systems – Analyst/ Tester - Contract
Publicis Selling Solutions; Lawrenceville, NJ- May – November 2005
Manager, Sample Accountability
Glaxo Smith Kline; Philadelphia, PA – March 2003 – May 2005
Senior Sample Accountability Analyst
Sample Accountability Analyst
P.D.M.A. Inc., (Wyeth Pharmaceuticals), Radnor PA: September 2001 – July 2002
Sample Reconciliation Administrator – Contract
Rhone-Poulenc Rorer Pharmaceuticals, Collegeville, Pa September 1991 – 2000
Sample Fulfillment Administrator
Computer Skills:
Microsoft Office applications, Excel, Word, Outlook web-based applications and mainframe-type systems
Pharmaceutical related: Sample Guardian, Remedy, Beacon (GSK), Trackwise, GREATS (J&J/ Iron Mountain), EPIC (Geisinger)
Education:
Manor College 2011: Medical Billing & Coding
Montgomery County Community College – Associates Degree: AFA-Blue Bell, PA - GPA 3.81
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