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Desire a contract opportunity
as a SAP R/3 QM Team Lead / Functional Consultant.
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Over twelve years of ERP
experience with SAP in Quality Management (QM) in the Petrochemical, Food
Chemical, Consumer Health and Pharmaceutical Industries including Computer
System Validation responsibilities.
I have successfully performed all required duties as a functional QM
resource, as a QM Team Lead, and as a Team Lead for Systems Validation for
various primary vendors as mentioned below.
SAP consulting experience consists
of internal and contract consulting and support of SAP QM. Implementation of 3.0C with an upgrade to
3.1I, implementation of QM functionality for existing 4.6B and 4.6C
installations, and full cycle implementation of 4.6C, 4.7, and ECC
6.0. Hands-on experience in
blueprint/design, QM configuration for QM in the process industry and
repetitive manufacturing, QM in procurement, production, and sales &
distribution. I successfully
implemented several QM functions including quality planning, quality
inspection, sampling, quality certificates, and quality notifications. I
have created QM Functional Designs for various reports, interfaces,
conversions, enhancements, and forms, working closely with technical
developers to implement these designs.
I have experience in legacy data organization and transfer, CATT
scripts, organizing and creating QM master data, writing and presentation
of training documentation and post implementation support. Experience in integration points of other
functional areas including BM/MM, SD, IM/WM, and PP.
I successfully lead the
Validation of the SAP ECC system according to GAMP 5 risk based validation
protocols.
Business experience includes 8
yrs of QM leadership responsibilities with process manufacturing and
quality assurance management assignments.
Four years CPG LIMS laboratory database administrator.
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7/2006
- 9/2009 Johnson
& Johnson / Neutrogena Skillman,
NJ / Los Angeles,
CA
SAP QM Team Lead / CSV
Validation Team Lead
I worked with Accenture
Consulting who was the primary vendor for the implementation of SAP ECC
6.0.
As the QM Team Lead I
successfully managed the team as we gathered requirements, designed and
built solutions, tested and validated the system, then guided the client
through cutover and a very successful go-live for the QM
functionality. I also added value in
helping with some hands-on activity in the Functional Design documentation,
security design, test script preparation and testing.
Core QM functions were
implemented as well as enhancing e-signatures, logical release with
external WMS systems, non-conformances in external systems and Quality
Notifications, early inspection lots from ASN, and dependent component
release and expiration dating.
I functioned as the
Validation Team Lead for subsequent J&J project releases including the
migration of Neutrogena into the J&J SAP instance. My responsibilities included
collaborating on project and validation methodology based on GxP best
practices and GAMP 5 risk based validation.
I successfully coordinated the timely completion of all validation
deliverables such as an updated project Validation Plan, business
requirements, functional designs, test strategy and testing protocols, the
validation of User Acceptance Test cycle, and final validation
reports.
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12/2004
– 5/2006 Shire
Pharmaceuticals Baltimore,
MD / Chesterbrook,
PA
SAP QM Team Lead
I was contracted as the QM
Team Lead for this project that was managed and implemented by IBM Business
Consulting Services. As the QM Team
Lead, I organized and lead the QM team through blueprinting, realization,
testing/validation, cutover and go-live activities. Among the tasks that I completed were
process analysis and mapping, configuration, final testing, QM
documentation and validation. The QM
processes included sampling using WM, inspection and digital
signatures. Quality Notifications were
designed for use in product and customer complaints, vendor audit recording
and Quality Info records for vendor control.
Final cutover activities
included static data validation and loading. I lead the post cutover support of
quality planning, inspections utilizing sample drawing procedures for
physical samples, and enhanced quality notifications using workflow.
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5/2004
– 8/2004 Celanese,
Acetate Division Dallas,
TX
SAP QM Consultant (Contractor)
I successfully configured the
QM system in a SAP 4.7 environment.
I was responsible for the configuration of output and profile
determinations, and implementation of certificates of analysis. I created CATT scripts to successfully load
all output determination and profile determination records. I gathered requirements and created
functional requirement documents for certificate enhancements and quality
data file interfaces.
I completed my assignment with
post-implementation support, trouble shooting and the completed
documentation of all configuration, transports and enhancements that I
performed.
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11/2002
– 4/2004 Wyeth
Pharmaceuticals Rouses
Point, NY / Phila., PA
/ Carolina, Puerto
Rico
SAP QM Consultant (Contractor)
Full implementation of SAP
4.6C in the Wyeth, Rouses Point and Carolina,
Puerto Rico manufacturing facilities. I was contracted through SAP America
to assist in legacy data organization and to successfully implement the QM
module with quality planning, inspections, digital signatures, audit
trails, and batch status management.
Performed post implementation support.
Additional experience from
assisting other functional areas in terms of integration points for MM/IM,
WM, PP and specialized reporting functions for inventory and quality
release controls. QM sampling using
general WM transactions.
Additionally, I worked as a
member of the training development team successfully developing and
delivering the core QM training curriculum.
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2/2002 – 8/2002 Chevron Phillips Chemical (CPC) Houston,
TX
SAP QM Consultant (Contractor)
I worked with CGEY to install QM in an existing
SAP 4.6b installation. The legacy
LIMS system was retained. I
successfully implement the QM module for transfer of quality data from LIMS
to SAP and to control inventory for distribution according to manufacturing
and customer specifications using batch determination.
I successfully implemented the QM module and
developed a custom interface for the non-certified StarLIMS system.
I set up the QM configuration, developed the
certificate forms specifications to consolidate over 40 legacy forms,
participated as a team member for data extraction, clean-up, and
loading. Wrote and used CATT scripts
for some legacy master data. I wrote
and presented training documents for the QM functions.
I have exposure and some experience in cross-over
functions such as SD and MM in terms of customer specifications (batch
search strategy), custom reports, reason codes for material movements, and
customer groups.
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8/2001 – 2/2002 Astaris Lawrence,
KS
SAP 4.6C Central Support (QM)
Functioned as the SAP Application Specialist
QM/ADC for Astaris LLC. Astaris is a
chemical manufacturer and uses SAP for a Process Industry. I was assigned the role of QM primary
support for the Astaris enterprise.
My duties were focused on issue resolution from post go-live and
phase 2 enhancements.
Post go-live support included monitoring and
resolving issues. Internal
consulting for design issues and extensive troubleshooting of master data,
using all available resources such as programming, basis and functional
teams as well as the SAP Solution Manager.
Phase 2 enhancements included improved inspection
plan design for specific process requirements, initiating and follow up of
requested programming, long term inspection and incorporating plant
maintenance for calibration inspection.
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6/2000 – 8/2001 Astaris Lawrence, KS
SAP 4.6C Implementation
Project
Approximately half of the
company was using SAP 3.1I and the other half was using a proprietary
package. The implementation was
approached as a new install of SAP 4.6C.
As an Astaris employee I
was appointed to the role of PTM (Process Team Member) for the QM (Quality
Management) module, to work full time on the implementation of the SAP 4.6C
project. This was the company wide
lead role for the QM module.
I successfully unified
diverse plants, work cultures and quality measurements in developing a
workable SAP solution. Organizing
and facilitating weekly teleconferences, periodic presentations and end
user training were among my duties.
As the PTM, it was my responsibility to engage the participation and
support of the Astaris laboratory personnel across the enterprise.
My training and experience
include:
QM training through SAP
Educational Services.
Using ASAP methodology, I
gathered data from the various sites for blueprinting the design of the
final product. In turn I created FDS
(Functional Design Specifications), wrote BPP (Business Process
Procedures), prepared functional testing scenarios and took the lead in
developing and writing the QM training documentation.
I performed the standard and
custom configuration in SAP QM. I
executed configuration troubleshooting as necessary in preparation for
module and integration testing.
I developed the master data
for module and integration testing.
Worked closely with the data
team to extract data from incompatible legacy systems into an Excel format.
Lead the plants in cleaning and modifying the master data in preparation
for the data load into the production system. I successfully met the challenges
presented by the various QM groups in addressing the data with their
limited resources and some negativity.
Conducted onsite training
for end users with various backgrounds in computer literacy.
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2/1997 – 6/2000 FMC Lawrence,
KS
SAP 3.0C / 3.1I QM Support (As Lab Coordinator)
As primary SAP QM support for the Lawrence
facility, I maintained all QM master data.
Worked closely with the central support team in the Philadelphia
location to resolve master data and basic design issues of our system.
I handled all of the QM training for the site for
existing employees and all newly hired during this time frame. I developed additional training documents
to facilitate the training of the newly hired.
I received a great deal of exposure to
cross-functional areas such as Shipping and Distribution (SD), Plant
Maintenance (PM) and Inventory Management (IM).
In 1998 I tested the QM master data and
configuration for the upgrade project from version 3.0C to 3.1I.
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11/1995 – 1/1997 FMC Lawrence,
KS
SAP 3.0C QM Implementation Team (As Lab
Coordinator)
For my first full implementation of SAP, I was
appointed to the role of the Lawrence
site QM lead. My experience was
quite vast. As a member of the QM
team, my responsibilities were:
To catalogue the Lawrence
quality systems in preparation for blueprinting.
I handled the entire QM data
scrubbing for the Lawrence
facility.
On hands training for master
data creation and integration.
Created all of the necessary
master data that was not part of the data load.
Attended outsourced train
the trainer program (3 days).
Assisted in development of
the training documentation.
I was the sole QM trainer
for the Lawrence facility.
I traveled to two other FMC
sites, (Green River WY.
And Carteret NJ.), on multiple occasions to aid in their training and
process troubleshooting.
I was part of the post
go-live issues resolution team for issues regarding Certificates of
Analysis and master data.
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1993 - 1995 FMC/Astaris Lawrence,
KS
Technical Specialist /
Laboratory Coordinator
Created CofA’s and
maintained Lawrence master data
through CPG LIMS.
Customer interaction
including customer inquiries and customer complaints.
Played a major role in
creating, organizing and maintaining Laboratory ISO 9002 documents.
Performed scheduling and day-to-day
work assignments for lab technicians.
Eight-month assignment as
Acting Chief Chemist.
Implementation of SAP QM
module for FMC Lawrence.
Eight-month assignment as
production Team Leader.
Awards received: Excel Award
and Quarterly Excel Award for Acting Chief Chemist, Excel Award for SAP
implementation.
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1986 - 1992 FMC Lawrence,
KS
Laboratory Technician
Performed quality assurance
analysis of product.
Maintained accurate record
of data in various formats.
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1975 – 1976 Brigham Young Univ. Provo,
UT
1976
- 1979 Oklahoma
State Univ. Stillwater,
OK
Recently Haskell
Univ. Lawrence,
KS AmeriComp Topeka,
KS
More
recent study to update and enhance chemistry skills. Successfully completed Networking and
Operating Windows 2000 Professional and Server as part of the MCSE Win 2000
certification program.
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1976 – 1978 Italy
Two years in Naples
and Rome as a representative
for a charitable organization.
Fluent in Italian.
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Available upon request.
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