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Summary: Strong experience with document editing, routing, filing, and retention

. Experience establishing documentation processes that comply with GMP and ISO13
485 requirements. Customer focused without sacrificing procedural requirements.
Experience in medical device and pharmaceutical companies, anatomical chart manu
facturing, and health care center.
March 2005 - Present
Eli Lilly and Company, Indianapolis, IN -
Associate Consultant - Quality Assurance
* Coordinates preparation, approval and distribution of new and re
vised documents related to GMP operations using appropriate document and record
management procedures
* Assigns and tracks workflow of core document controllers, techni
cal writers, GMP Librarians and Distribution Coordinator
* Revises and creates document and record management procedures, m
anages the external Standards library, serves on the EDMS governance committee
* Oversees the periodic review of GMP document including Standard
Operating Procedures (SOPs), the Quality System Record, Quality Plans, contracts
and agreements
* Advises and coaches document owners and authors in both business
processes and use of electronic tools such as Regulus, TrackWise and NetTrax
* Generates metrics to report the process and initiate continuous
improvement, submits and presents metrics to Management and Quality Lead Teams
* Participates in Six-Sigma Teams for document and records managem
ent process improvement initiatives
* Uses the following software applications as a Power User
TrackWise for Change Control
TrackWise for CAPA (Lead Investigator, Document Control)
Regulus (EDMS)
NetTrax (Records Management)
July 2004 - March 2005
Eli Lilly and Company, Manassas, VA
Senior Project Engineer
* Assisted in the development of project and GMP document and reco
rd control system for the management of GMP and non-GMP (construction/project) d
ocuments and records to support the building and validation of an insulin-produc
tion facility
* Created document and record control procedures, and associated w
ork instructions and forms to manage project document control
* Coordinated the completion of physical inventory of contents of
Document Control Center in preparation for new design activities
* Member of Document Management Team, co-authored charter for Team
February 2003 - July 2004
MedImmune, Inc., Frederick, MD
Manager, Quality Assurance Documentation
* Coordinated EDMS Help Desk, including trending and resolution of
problems
* Managed staff of 7, including a supervisory level employee, prov
iding coaching, mentoring, and oversight of training requirements
* Implemented system for periodic audit of hard copy point-of-use
manuals, including streamlining distribution of hard copies, and eliminating dup
lication of distribution through EDMS
* Managed company-wide training associated with the electronic doc
umentation system, ensuring that the training materials were accurate and effect
ive, and participating in training sessions as the subject matter expert
* Served on EDMS Task Force coordinating resolution of non-conform
ances to EDMS process and procedures
* Functioned as EDMS Systems Administrator
* Served on EDMS global project team
* Assisted with globalization of Corporate System Procedures for d
ocument and record control, including EDMS procedures by analyzing 21CFR210 and
211, ISO9000, EU and 21CFR810 regulations against current procedures
January 1998 - February 2003
Digene Corporation, Gaithersburg, MD
Manager, Document Control
Supervisor, Document Control
Document Specialist II
* Maintained processes and staff for document management to provid
e efficient processing, effective control and compliance with corporate quality
system requirements
* Directed activities of Document Control staff to ensure tracking
of priorities and workload to meet operational timelines and departmental objec
tives
* Ensured appropriate training of Document Control staff, provided
coaching as appropriate
* Established metrics to continuously review performance of docume
nt management functions, reporting performance monthly, and implementing correct
ive as appropriate in response to those metrics
* Established and maintained processes for electronic document acc
ess
* Coordinated activities related to providing required documentati
on and implemented related documentation systems
* Coordinated periodic review of quality system documents
* Designed and maintained all Document Control databases
* Reengineered entire department, reducing hand-offs and streamlin
ing change control process
* Conducted internal audits as part of internal audit team on a se
mi-annual basis
* Reduced change order turnaround time by 200% within 1 year
* Reduced change order backlog within 6 months of department reorg
anization
* Summarized change controls for inclusion in annual report
EDUCATION AND AFFILIATIONS
1968 DePaul University, Chicago, IL (Major in English, Minor in Education)
1994 Completed a 10 week course in Statistical Process Control presented by ASQ
1994 Completed training for Batch Record Review and Investigations
1995 Completed ASQ's Writing Quality Systems Documents
1996 Completed AARMA Records and Information Management Home Study Program
2002 Potomac College, Washington D.D., B.S. Management, 3.94 GPA,
a. Graduated with highest GPA in graduating class
b. Received Founders Award for Outstanding Contribution to the Workplace
2003 GERM Conference, Good Electronics Records Management for the FDA, managing
Part 11 Requirements
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