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Pharmaceutical compliance, Document Control, Pharmaceutical samples

Elkins Park, Pennsylvania, 19027, United States
30.00 hrly
July 19, 2018

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Mary V. Pearson

Elkins Park, PA *****


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)


Manor College 2011: Medical Billing & Coding

Montgomery County Community College – Associates Degree: AFA-Blue Bell, PA - GPA 3.81

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