Document Control Project Manager
Resume:
.Loretta A. Clemmans
Geneva, IL. 60134
********@*********.***
Successful background of managing quality document control and retention
systems. Especially skillful at seeing opportunities for process
improvements, translating into specific objectives, assist in creating
project plans, marshaling necessary resources, and managing through to
completion. Proven delivering significant and sustainable efficiencies
and cost reductions.
Extensive professional skills and experience including:
. 22 years working in pharmaceutical/medical device industry
. Own and Manage Document Control Process
. Managing Design Transfer and Release
. Manage ECO /Deviation Process and Implementation
. Strong analytical reasoning and problem-solving skills
. Hiring, Training, Coaching &Team Building
. Document Control Subject Matter Expert
. Ensuring ISO,QSR/cGMP,GLP Compliance
. Improving Processes, Procedures & Productivity
. Sub-Admin for GE Healthcare's Electronic Document Management System
. Implementing and Validating Electronic Document Management Systems
GE Capital Americas December 2011-
Present
Records Manager Lead
Assist and train functional areas on records management requirements.
Worked with functional teams to decrease working copies of records
inventory. Participated in the development of Records Information
Management Assessment and Maturity Model Program with the Audit and
Policy Team. Project Manager for RIM Maturity Model 3 Pilots and
Rollout to 18 Platforms. Completed data analysis from RIM Maturity
Models and assisted in identifying risk and remediation plan to senior
management. Developing with Policy and Audit Team control points for
Records Managers which will be used in deployment for Platform RIM
Assessments.
GE Healthcare
Integrated Information Technology Systems
Manufacture: Medical Device Software
Documentation Leader July 2008-
December 2011
Developed hands on training for MyWorkshop users. Delivered training to
over 2000 employees for MW ILT. Developed Document Control Point Person
Training material and curriculum. Delivered training to 11 new
Enterprise Document Control Point people. Obtained a role in MyLearning
as a MyLearning Administrator. Training in process to become a
MyLearning Power User. . Responsibilities include leading the
activities of (13) Document Control Point peoples (indirect reports) in
the Document Control group. Accountable for ensuring regulatory
compliance and optimization of quality system procedures relating to
Document Control and EDMS MyWorkshop. Provide technical support as a
Junior Librarian to employees for the MyWorkshop EDMS document central
side of the tool. Developing a Document Change Control process for HCIT
and the sites to be piloted by 31 December 2010. Received a presidents
award in recognition for efforts in regards to 2009 FDA inspection "No
483's. Received a Your GE You Made a Difference Award from Chris
Nocchi/Product System Engineer for improving design efficiency.
Received a Healthcare Heroes Award from Janet Morris/Senior Design
Engineer for delivering special refresher training on MW to her team.
Janet L Morris
Quality System Specialist Process Leader May
2006-July 2008
Appointed by QA/RA GM to Global Document Management and Communications
Council for GE Healthcare. Leading document control in GE Healthcare
quality management system reset rollout. Phase one implemented
successfully. Awarded Global Management Award for successfully
implementing Phase One of GEHC Documentation Reset. Responsibilities
include leading the activities of (12) coordinators (indirect reports)
in the Document Control group. Accountable for ensuring regulatory
compliance and optimization of quality system procedures relating to
Document Control and Training through development, maintenance and
improvement of documented processes. Develop and deliver Presentation
Training on Document Control and EDMS MyWorkshop. Develop Global Work
Instructions for GEHC businesses. Developed and maintain an efficient
document system across 19 GEHC IITS sites in compliance with ISO and FDA
requirements. Librarian (System Administrator) for EDMS MyWorkshop.
Resolve employee issues with EDMS serving all GEHC IITS employees
(5000). Development and implementation of quality metrics to drive
improvement and business results. Remote training management.
Maintenance of Documents via EDMS. Deliver training on accessing
External Standards and Specs owned by third party service. . Promoted
to Documentation Leader, July 2008.
Kavo/Gendex Dental Systems, Des Plaines, IL
Dec. 2004- May 2006
Manufacture: Digital Imaging Dental Equipment
Sr. Document Control Specialist
Responsibilities include managing the activities of (3) three
coordinators in Document Control group. Accountable for ensuring that
all written procedures, bills of material and Engineering Changes
Notices (ECN's) and Deviations are accurately completed, entered,
updated and tracked in the system. . Project leader for
implementation of new Electronic Document Management System/ Master
Control. Leading team to import 30,000+ documents into the Master
Control system. Configured the Master Control system and performed
validation of the system. Responsible for delivering power user and
user training for Master Control to 140 employees. System
Administrator for Master Control- document control/training/CAPA/change
control software. Entered and updated bills of materials and revisions
using the BPCS systems; maintain ECN and deviation log and database.
Coordinated Design Engineering releases; prepared and distributed
documentation packages. Change Control Administrator. Chaired Change
Control Meetings. Produced reports for metrics on Change Control.
Maintain engineering electronic documentation files. Train new hires on
engineering change control and good documentation practices. Review
and maintain bills of material structure for new products to ensure
accuracy. Managed the Design Transfer of new product document to
Production Maintained departmental training records, external
standards library, Master Doc Database, and master sets of the Quality
Manual, operating procedures and Work instructions, specs and drawings.
GE Healthcare (formerly Amersham Health), Arlington Heights, IL
June 2001-Nov. 2004
Manufacture: Pharmaceuticals/Medical Device
Document Control Team Leader
Responsibilities include managing the activities of (8) eight
coordinators in the Document Control Group. Ensuring that sound
regulatory practices are integrated in the Document Control systems.
Providing internal customer services to 230 employees. Author and
revise new/current departmental Standard Operating Procedures to ensure
FDA compliance. Phased out paper change control and document control
process. Implemented EDMS for Change Control and Document Control.
Leading team to import 20,000 documents. Managed Deviation Process.
Performed validation testing on the implementation of an electronic
document management system. . Coordinated/chaired meetings related to
the electronic management system project Trained on new EDMS as Power
User. Delivered training to employees on new EDMS. Organizing and
conducting internal audits. Processing/writing Change Controls.
Preparing and presenting a variety of training on Document Control
topics. Managing/issuing effective documentation to appropriate book
holders. Accountable for Pro Card purchases and reconciliation of
monthly statement. Approving DC invoices for payment. Maintaining a
database consisting of all controlled documents and associated Change
Controls. Maintaining Excel spreadsheets for Lab Notebooks and Batch
Records. Responsible for all off site archiving of controlled
documents. Authorize via E-Time vacation/sick hours for non-exempt
Quality Assurance employees. Hired as a Document Control Coordinator,
performing complex word processing for controlled documents and
issued and reconciled Batch Records. Promoted to Document Control Team
Leader 6 month after hire date.
Coperion Corp. (Buss, Waeschle, Werner Pfliederer), Bloomingdale, IL.
Sept. 1998 - May 2001
Manufacture: Kneaders, Extruders, and Related Batch Processing
Equipment
Spare Parts Sales Representative-Food Processing
Placed spare parts and machinery repair orders. Researched operation
manuals, bills of materials and technical drawings to develop customer
quotes. Calculated currency conversion and export/NAFTA documentation.
Trained outside Sales Reps on customer support procedures. Hired as
Sales Administrative Assistant to prepare written quotes, lab trail
reports and customer mailings. Maintained MSDS documentation. Promoted
to Spare Parts Sales Representative 6 months after hire date
Siemens Medical Systems, Hoffman Estates, IL Jan.
1977- Feb. 1992
Manufacture: Medical Nuclear Imaging Cameras
Engineering Change Administrator
Coordinated Design Engineering releases. Prepared and distributed
documentation packages. Chaired Change Control Meeting. Coordinated
the implementation of Engineering Change to Production Planners.
Audited and closed Engineering Changes files per FDA and GMP guidelines.
Maintained database for Engineering Change Control and Bill of Material
maintenance. Trained new hires on Good Documentation Practices.
Production Control ECN Coordinator
Developed implemented and maintained data base for Engineering Change
controls. Coordinated Engineering Changes with Machine Shop, PC Board,
Cable and Harness, Materials Management, Test Engineering, Field
Service, and Customer Service on all aspects of the Change Control.
Documented details for Change Control implementation for FDA compliance.
Promoted to Engineering Change Coordinator Hired as Secretary to the
Director of Field Service/Sales to coordinate and compile field service
reports, maintain database for field service technicians; plan and
organize district/regional field service/sales meetings, make travel
arrangements. Promoted to Production Control Engineering Change Notice
Coordinator.
Education and Training
Foreman High School, Chicago IL.
Elgin Community College, Elgin, IL - Certified Herbalist
Certified Notary for the State of Illinois
Certified Senior Administrator Master Control EDMS
Jr. Librarian For MyWorkshop
MyLearning Administrator
Memberships: ASQ, National Notary Association
Proficient in Microsoft Office (Word, Excel, Access, PowerPoint),
Documentum, TrackWise, Master Control, Comserve AMAPS, BPCS, E-Time,
MyWorkshop. MyLearning. Certified training in Good Documentation
Practices, GMP, ISO Guidelines, Preparing for and Passing a FDA
Inspection, Supervisory Skills, Safety/Security for Manufacturing
Environments, and training. Certification in GE Healthcare Leadership.
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