Paula Michelle Stallings

Auditor, GCP Quality Systems at United Therapeutics Corporation

Raleigh-Durham, North Carolina Area

Pharmaceuticals

United Therapeutics Corporation - RTP since Aug 2012
Auditor, GCP Quality Systems
Novella Clinical, Inc. May 2007 - May 2011
QA Associate
bioMerieux, Inc. 2006 - 2007
Quality Engineer
Teleflex Medical 2004 - 2006
Quality Specialist Medical Affairs
Salix Pharmaceuticals 2003 - 2003
Clinical Research Coordinator

FDA
Validation
cGMP
SOP
Change Control
Sop
GMP
CAPA
Quality System
GCP
Medical Devices
Quality Assurance
ISO 13485
ISO
Clinical Trials
Quality Auditing
21 CFR Part 11
Software Documentation
Root Cause Analysis
CRO
Clinical Research
Regulatory Submissions
V&V
Regulatory Affairs
Biotechnology
Continuous Improvement
Pharmaceutical Industry
CTMS
Document Management
GLP
EDC
Quality Control
Design Control

Wendell, NC

Pharmaceuticals

United Therapeutics Corporation - RTP since Aug 2012
Auditor, GCP Quality Systems
Novella Clinical, Inc. May 2007 - May 2011
QA Associate
bioMerieux, Inc. 2006 - 2007
Quality Engineer
Teleflex Medical 2004 - 2006
Quality Specialist Medical Affairs
Salix Pharmaceuticals 2003 - 2003
Clinical Research Coordinator

Fda
Clinical Trials
Capa
Sop
Gcp
Quality System
Pharmaceutical Industry
Quality Assurance
Cro
Medical Devices
Clinical Development
Quality Auditing
Validation
Biotechnology
21 Cfr Part 11
Gmp
Protocol
Regulatory Affairs
Change Control
Regulatory Requirements
Clinical Data Management
Oncology
Ctms
Glp
Iso 13485
Software Documentation
Edc
Regulatory Submissions
Gxp
V&V
Biopharmaceuticals
Ich Gcp
Clinical Research
Quality Control
Data Management
Clinical Monitoring
Trackwise
Document Management
Clinical Operations
Management
Life Sciences
Computer System Validation
Ind
Iso
Root Cause Analysis
Continuous Improvement
Design Control
Cleaning Validation
Tmf

Civil Rights and Social Action
Environment
Science and Technology
Human Rights
Animal Welfare
Arts and Culture
Health

English