CONNIE MASTERMAN 
5606 Freedy Ave. 
Racine, WI 53406
HOME:  [Send email to request phone number] 98-8257 
CELL: (815) 718-5869 
E-MAIL: 

Validation Quality Manager

17 Years of Validation, Project Management, Auditing, & Laboratory Experience

9 Years as Validation Manager, 5 Years as Quality Supervisor, 3 Years as
Internal Auditor
 
SDLC Development
SDLC Implementation 
Process Development

21 CFR Part 11 Evaluations
Certified Internal Auditor
Compliance Monitoring

ISO Implementation
Multiple Project Management
Proven Training Ability
 
HIGHLIGHTS OF QUALIFICATIONS

* Validation Manager for software and equipment projects to meet customer
requirements.
* Promotable hands-on Manager with proven results implementing continual process
improvements to maximize operating effectiveness for internal and external
customers.
* Known as results-oriented highly intelligent individual with strong
leadership, team building, and problem solving abilities. Rapidly assimilates new
technology and processes.
* Effective communicator with ability to interface and build rapport with all
levels of management, subordinates, vendors, peers, clients and technical
specialists.
* Skilled trainer with a solid history of creating and facilitating employee
training in the areas of new equipment operation, policies, procedures & work
instructions in support of FDA regulations, customer requirements and quality
initiatives.

PROFESSIONAL EXPERIENCE

Edstrom Industries, Inc.
2005  *  Present
Manufacturer of automated watering systems, watering purification, access
control, lighting control, environmental monitoring and workflow management
within research facilities (GLP/Academic).

Validation/Quality Manager 
* Validation of GLP/GMP customer systems including project management,
developing testing plans/protocols, designing requirements, documenting actual
results, analyzing/documenting deviations, preparation of final reports and
approvals.
* Managed validation team to meet customer  's requirements and schedules.
* Developed and implemented evaluation process for ensuring Edstrom  's product
compliance to 21 CFR Part 11 (Electronic Records & Signatures regulation).
* Responsible for monitoring compliance of software and equipment requirements
to 21 CFR Part 11, 21 CFR Paert 26 (GMP regulation) 21 CFR Part 58 (GLP
regulation) and 21 CFR Part 820 (Quality System regulation).
* Responsible for developing, implementing and monitoring the Software
Development Life Cycle (SDLC) process to comply with GLP/GMP regulations.
* Developed and implemented customer satisfaction process.
* Liaison for customer and vendor audits.
* Developed processes for ISO 9001:2008 implementation.
* Conducted internal audits in support of ISO 9001:2008 implementation.
*Company President appointed chairperson of Employee Communication Committee.
* Member of Engineering Corrective Action team.

Abbott Laboratories  *  Diagnostics Division (ADD)1993  *  2005
A global, broad-based health care company devoted to discovering new medicines,
new technologies and new ways to manage health.

Laboratory Information Management System (LIMS) 2000  *  2005 
Validation Manager (GMP Data Management System) 
* Led a software validation team of 2-5 people
* Successfully led the ATLAS LIMS conversion and lab start up for the Abbott
PRISM 
(blood banking evaluation medical device) teams at the Abbott Germany site.
* Successfully trained 72 technicians on the use of LIMS with Abbott PRISM
Instruments and Abbott PRISM Standalones at the Abbott Germany site 2004.
* Conducted 12 various LIMS training classes in 2004 for a total of 127
trainees.
* Reorganized LIMS validation strategy to streamline testing per divisional
policies
* Project liaison between management and Software Quality Group.
* Received ADD Vice Presidents Award for outstanding efforts of LIMS
deliverables 
* Validated an ad hoc query program in response to an FDA audit for aberrant
value routines  *  Received divisional Quality Assurance/Regulatory Assurance
Award of Excellence for contributions.
* Developed, validated and implemented LIMS versions 2.5, 2.6, 2.62, 2.63, 3.00,
3.10, 3.20, 4.00, 4.10, 4.20, 4.30 and all subsequent patch releases of the
Abbott World Wide LIMS in time to meet production/customer needs.
* Participated in third party and FDA audits  *  completed third party audit of
the LIMS release version 3.00 with approximately 300 test scripts and no
observations.
* Managed day-to-day activities of validation team personnel, budgets and team
projects.
* Maintained LIMS per SLC (Software Life Cycle) requirements.
* Successfully completed validation to upgrade LIMS to be 21 CFR Part 11
compliant within given timelines.

Senior Quality Support Specialist (QSS) 
1997  *  2000
Abbott PRISM Quality Unit (GMP Laboratory)

*Abbott PRISM Data Reduction System Administrator.
*Supervised daily activities of QSS staff.
*Responsible for upholding quality policies in the business team (BT) testing
labs.
*Validated, implemented and trained personnel on failure investigation
software.
*Identified compliance gaps within the Abbott PRISM Data Reduction System (DRS)
and then developed, validated and implemented versions 3.0 and 4.0 of the Abbott
PRISM Data Reduction System. 
*QSS representative during FDA, divisional and site audits.
*Responsible for formulating responses and guiding follow up of site audits.
*Quality contact for HIV O Plus assay group.
*Scheduled testing validation activities for the HIV O Plus assay.
*Schedule testing workflow for BT and QSS personnel.
*Developed CBER (Center for Biologics Evaluation and Research  *  FDA) protocol
along with Quality Assurance and Regulatory Affairs for US market launch.
*Abbott PRISM instrument and QSS subject matter expert.

Product Specialist/R&D Technician 
1993  *  1997
*Coordinated and performed proof of performance testing.
*Participated in validation of component processes for HIV assay final
formulation.
*Implemented DOE (Design of Experiment) modeling HIV assay optimization.
*Developed, validated and implemented macro software for DOE modeling.
*Designed, executed and evaluated testing protocols to improve product
performance and to formulate testing and manufacturing procedures.
*Developed and facilitated Abbott PRISM Operator  's Training (Lake County)
*HTLV (Human T-Lymphotropic Virus) assay optimization and troubleshooting.
*HBcore/HBc (Hepatitis C) assay product support, maintenance and improvements.

CONTINUING EDUCATION

FDA Preparedness, BSI Internal Auditor Training ISO 9001-2008, GAMP 4 (Good
Automated Manufacturing Process) Training, Project Management, First Aid/CPR/AED

EDUCATION

Bachelor of Science in Biology  *  University of Wisconsin - Parkside

REFERENCES

Available upon request