CAROLYN ROWE

126 Cotton Court

Residence: 863-968-0268 Auburndale Florida
33324
Cell: 863-703-9161
Email: cr7d6fc4@westpost.net
SUMMARY
Detail oriented, reliable and organized Quality Auditor and Quality Professional
with extensive experience in a fast paced deadline oriented, quality focused ma
nufacturing environment. Extensive experience in Quality Auditing. Possess excel
lent analytical, observation, people and communication skills. Known for high d
egree of Current Good Manufacturing Processes (cGMP) ISO and , Corrective and Pr
eventive Action (CAPA), Quality knowledge. Reputation as a self-starter who perf
orms well individually or as part of a team. Proven Skills in Total Quality Man
agement (TQM) Quality System Regulations (QSR). Clear communication skills both
orally and written. Key strengths include:
cGMP ISO Standards
ASQ Quality Auditor
Managing Multiple Priorities CAPA
Manager
Supervisor Dependable
Customer focused
Flexible Work smarter not
harder
PROFESSIONAL EXPERIENCE
Consultant- Quality Auditing/Specialist
2009-2010

Watson Pharmaceuticals,Inc, Davie, Florida

2003-2009
a Senior Compliance Auditor. Audited suppliers and all areas of manufacturing fa
cilities to insure departments were in compliance with Food and Drug Administrat
ion (FDA), cGMP regulations. If not compliant assisted in resolving non complian
t findings and the necessary steps to correct to finding(s).
a Change Management, Quality Specialist
Senior Compliance Auditor
a Reduced audit findings in first year 75% and assisted departments with solutio
ns on how to eliminate problem areas. Continuous improvement followed.
a Trained employees to become auditors. Members from other teams were invited to
become active in the auditing process in order to eliminate deficiencies in the
ir areas as team players.
a Audited current and prospective suppliers to insure outside contractors were F
DA compliant.
Change Management Quality Specialist
a Under general supervision, managed the manufacturing deviation system and proc
esses to assure compliance with cGMP and FDA requirements. Functioned as system
operator of Trackwise and Qumas software. Under general supervision, managed the
changes related to company and contract manufacturing from initial proposal to
successful implementation.
a From implementation through completion, approved and distributed over 400 chan
ge controls in one year.
a Goals of reducing outstanding open change controls was accomplished. Over 450
change controls were open and in less than six months had been reduced to below
150. Goals of maintaining open change controls to below 150 per month was met a
nd maintained. Weekly team goals of no more than 5 change controls to be proces
sed was met. Most recently a higher goal of no more than 1 daily was achieved.
a Customer oriented department, customers care was the number one goal.
Implant Innovations, Inc (3i), Palm Beach Gardens, FL
2002-2003
a Quality Engineer/Auditor for manufacturer of dental implants and related produ
cts.
a Investigated and resolved over 150 complaints, including failure investigati
on, root cause, corrective and preventive action (CAPA)
a Completed over 25 Supplier and Internal quality audits.

Carolyn Rowe
Page Two

Diamond Products Company, Seffner, FL

2000-2001
a Corporate Quality Auditor/Specialist for a manufacturer of over the counter ph
armaceutical/consumer products for two facilities.
a Over 20 Supplier and internal cGMP and ISO audits. Prepared and revised proce
dures. Investigated and resolved of complaints using Corrective and Preventive (
CAPA). Assisted Regulatory Affairs (RA) and R&D as needed.
a FDA cGMP, QSR , Safety and Standard Operating Procedure (SOP) trainer.
Telephone Services, Inc, Brandon, Fl
1998-2000
a QA Manager for manufacturer of custom communication cables, equipment.
a Team leader of all Quality functions. Demonstrated ability in customer relati
ons, problem solving and communicating effectively to upper management. Reduced
quality issues over 50% by training manufacturing teams in more effective and p
roductive quality oriented production methods.
Flexsite Diagnostics, Inc., Palm City, FL
1997-1999
a Quality Assurance (QA) Manager for manufacturer of medical Diagnostic Kits.
Established the Quality department. Created all Operating, Work and Inspection p
rocedures in compliance with FDA, QSR, cGMP and ISO. Responsible for administeri
ng all aspects of in house quality systems, including Documentation, Receiving o
f Incoming raw materials, In Process, Final inspection and release of Finished p
roducts.
a Administered Audit program including departmental and supplier quality audits.
a Company Safety and training coordinator.
Baxter Healthcare Corporation, Dade Division, (Baxter, Dade division) Miami , FL

a Technical Services Specialist, Auditor, Trainer and Complaint Coordinator. Ab

ility to troubleshoot customer problems pertaining to instruments, products manu
factured by Baxter, Dade division.
a Audited departments to insure compliance to cGMP, FDA regulations. Resolved c
omplaints domestically as well as international divisions.
a Supervised all QA/QC testing, biological as well as functional on diagnostic i
nstruments manufactured by Baxter, Dade division. As Team leader reduced testing
time on instruments over fifty percent by streamlining testing methods and stil
l meeting quality standards.
a Supervised blood bank functions.
a Functioned as an assistant to Research & Development (R&D) in performing Pilot
testing for coagulation, blood bank and chemistry analyzers.
a Medical technician performed QA/QC final release testing on reagents manufactu
red by Baxter Dade division.
EDUCATION
Bachelor of Science, Palm Beach Atlantic University, FL
Nova Southeastern University, Davie, FL
MT, Charron Williams Medical Technology College, Miami, FL
Further Studies,
Florida Southern College, Lakeland, FL
University of Wisconsin, Madison, WI
TRAINING
Quality Auditor, Quality Leadership Program, Advanced Supervisory Management
Just In Time Manufacturing, Managing Multiple Priorities, Exception Reporting,
Qumas Management System, Trackwise, J.D. Edwards, ISO 9002,
Current Good Manufacturing Process, Pharmaceutical and Medical Device,
Visual Manufacturing Management, Electronics for Non Electrical Engineers, ISO T
rain