Document Manager
Resume:
LINDA M. TRIPOLITIS
King of Prussia PA 19406
***************@*****.***
Summary
Highly knowledgeable, technically astute Quality Professional with over 30 years of combined experience in quality assurance, regulatory compliance, document management, training coordination, and basic research in both pharmaceutical and academic settings. Organized, efficient and resourceful Document Manager with over 10 years of experience effectively managing an Electronic Document Management System (First Doc.) Successfully released and implemented an EDMS across both research and manufacturing divisions. Solution-oriented and customer focused, provided comprehensive training and support to ensure users are well versed in all aspects of the system. Lean Six Sigma Yellow Belt.
Freelance Consulting Positions 2014 – 2017
PPD, Home-based - Clinical Management, Remote Site Monitor (4/14 - 08/17)
Responsible for remote monitoring of clinical test sites
Merck & Co. Inc., Upper Gwynedd, PA - Regulatory Affairs International, Document Specialist (1/17 - 4/17)
Responsible for management/procurement of ancillary docs to support global marketing of Keytruda
DePuy Synthes (Johnson & Johnson), West Chester, PA – Training Coordinator/LMS Admin (08/15 - 04/16)
LMS Administrator - managed the operation, maintenance, usage, analysis and administration of the Learning Management System
Executed transactions within the LMS including creation of user accounts, providing user and administrator access/rights, deploying course assignments, recording training completions, and administration of qualifications
Worked cross-functionally with all departments and management to ensure that training requirements and complaints were accurately documented
Collected and compiled quality data for reports; performed follow-up action and generated metrics
Assisted with the LMS migration to the new Learning Management System, Summit - Cornerstone OnDemand
Participated in FDA inspection by fulfilling all document requests.
Discovery Labs, Warrington, PA – Document Management (12/14 - 03/15)
Acted as Document Manager to cover for an employee's maternity leave
Maintained quality systems and managed all process/product documents
Maintained policies and standard operating procedures to ensure regulatory compliance with standards, guidelines and regulations
Responsible for inventory, routing, and tracking of all controlled documents including review, verification, and approval processes
Assisted in Regulatory and Agency audits by acting as the Document Control contact
Alpha Sights, Hong Kong – EDMS Harmonization (Teleconference 01/15)
Hired as a consultant - Subject Matter Expert for implementation of EDMS (Electronic Document Management System)
Discussed best practices and offered guidance on EDMS implementation and harmonization
Professional Experience
Merck & Co. Inc., West Point, PA 2009-2013
Quality Assurance Specialist - Merck Manufacturing Division
Site Steward - Merck's Electronic Document Management System, "MIDAS" (a product of FirstDoc)
Manager - MMD West Point Document Center
Three roles were concurrent. Directed a complex project to ensure full electronic document management system (EDMS) implementation and support for Merck Manufacturing Division.
•Managed a site-wide Document Center to provide EDMS support, administration of workgroup teams, communication cascades, and conducting of yearly system audits.
•Provided "live" EDMS training to all internal manufacturing groups and external sites to include Global Merck organizations, in excess of 800 people.
•Enhanced the site's GMP compliance status by developing and implementing processes to manage all critical documents within the EDMS.
•Developed custom EDMS queries and helped to resolve non-value added activities in order to run more efficiently.
•Created a new SOP Management System, and worked to ensure seamless operation of new system in order to decrease SOP approval cycle time by 5 days.
•Initiated and led bi-weekly SOP Core Team meetings to discuss issues and best practices with all Document Center personnel in order to ensure consistency and compliance.
•Initiated and led an SOP Community of Practice to share best practices with document managers across the manufacturing division.
•Supported the migration of new Learning Management System by preparing over 6000 SOPs for migration, and building over 2400 SOP courses, post-migration
•Acted as Inspection contact (FDA, TeamBio etc.) for EDMS Document Retrieval for Merck's Manufacturing Division
•Acted as technical writer for Regulatory inspections (eg. Team Bio Inspection at Merck & Co. Inc., Feb 2013)
Merck & Co. Inc. and PPD Vaccines & Biologics, Wayne, PA 2002-2009
Sr. Regulatory Compliance Coordinator - Merck Research Laboratories
Quality Specialist - Data, Facility, Procedural Audits
Project Manager for departmental EDMS ("MIDAS") release, migration & implementation for
Merck Research Laboratories. Served as departmental representative to support harmonization of EDMS migration across departments; This initiative included working with 7 preclinical areas to provide a common solution, foundation and methodology for supporting electronic document management requirements. Managed a contract employee to assist in 2008 site-wide archiving initiative
•Managed project to establish and maintain departmental Documentation Archive System to include electronic storage.
•Acted as Project Manager for establishment and administration of facility Imaging System (Kofax Ascent Capture) and Electronic System Repository.
•Performed QA Clinical Assay Data Audits for General Serology Labs to ensure GMP Compliance.
•Developed a tool to capture Compliance Business Indicators (review and approval efficiency) for SOPs/Change Control/Training
•Ensured compliance by acting as "Point of Contact" for Mumps, Measles, Rubella, Varicella, Zoster, Haemophilus Influenzae type B, Hepatitis A, Hepatitis B, Pneumococcal, PR5I, Cancer, and Alzheimer's Disease Clinical Testing Programs.
•Provided regulatory guidance and ensured compliance by providing assistance and responding to questions from personnel, collaborators, external laboratories and regulatory agencies.
•Ensured laboratories are inspection-ready by assisting in routine facility audits.
•Co-chaired quarterly Quality/Compliance Meetings to enhance communication between groups.
Merck & Co. Inc., West Point, PA 1998-2002
Staff Biologist - Merck Research Laboratories
Performed biological assays in support of Varicella, MMRV, Rotavirus & HIV Programs
•Conducted Varicella vaccine plaque assay according to SOP for the support of monovalent and combined vaccine products.
•Created and qualified an MRC-5 Master Cell Bank for analytical use.
•Developed and validated Rotavirus Plaque Assay with Sephadex Overlay.
•Qualified and characterized MA104 Master Cell Bank for use in Rotavirus Plaque Assay.
•Conducted Microtiter Infectious Unit (MIU) Assay for HIV.
•Performed Polymerase Chain Reaction for detection of Mycoplasma.
•GMP Laboratory Maintenance.
•Administrative Support for Cell Culture and Potency Assay Group.
Additional Experience
Hahnemann University 1984-1997
Biologist - Malignant Hyperthermia Research Laboratory, Department of Anesthesiology, Philadelphia, Pennsylvania
Education
B.S. Biology, Muhlenberg College - Allentown, PA
Awards
Merck & Co., Inc. and PPD Vaccines and Biologics, LLC
1. Award of Excellence - Nov 2012 (VVSS Project in D230 and LP29-01 Sterilization Project in D173)
2. Award of Excellence – May 2012 (COMET SMF updates and Bulk Pneumococcal Polysaccharide SMF redesign)
3. Award of Excellence – April 2009 (HPV testing initiative)
4. Award of Excellence – December, 2008 (From MRL-IT for MIDAS Rollout)
5. Team Award – September, 2008 (V&BR MIDAS Migration)
6. Divisional Staff Award – December, 2007 (Project manager for V&BR MIDAS Implementation and Migration)
7. Winner Merck "Most Amazing Woman" of 2007 – September, 2007
8. Award of Excellence – July, 2007 (Project Manager for MRL-Wayne "Take Your Child to Work Day")
9. Special Achievement Award – August, 2006 (Gardasil Campaign)
10. Award of Excellence – December, 2003 (Purchase and implementation of Imaging System for MRL-Wayne)
11. Award of Excellence – July, 1999 (Potency Assay of critical Urea Spiked Varicella samples for clinical release)
Publications List Furnished Upon Request
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