Resumes
Resumes

Senior Compliance Specialist
View pageLocation:
Jacksonville, FL
Industry:
Medical Devices
Work:
Gforce Life Sciences Nov 2016 - May 2017
Senior Quality Assurance Consultant
Johnson & Johnson Vision Care, Inc. Nov 2016 - May 2017
Senior Compliance Specialist
Mckesson Mar 2010 - Apr 2016
Quality Assurance Regulatory Affairs Manager
Microtek Medical Jul 2009 - Feb 2010
Sterilization Validation Supervisor
Biomet Jun 2002 - Jul 2009
Regulatory Compliance Specialist
Senior Quality Assurance Consultant
Johnson & Johnson Vision Care, Inc. Nov 2016 - May 2017
Senior Compliance Specialist
Mckesson Mar 2010 - Apr 2016
Quality Assurance Regulatory Affairs Manager
Microtek Medical Jul 2009 - Feb 2010
Sterilization Validation Supervisor
Biomet Jun 2002 - Jul 2009
Regulatory Compliance Specialist
Education:
Columbia Southern University 2014 - 2016
Master of Science, Masters, Organizational Leadership Washington County High School 1987
Columbia Southern University
Bachelors, Bachelor of Science, Occupational Safety
Master of Science, Masters, Organizational Leadership Washington County High School 1987
Columbia Southern University
Bachelors, Bachelor of Science, Occupational Safety
Skills:
Medical Devices
Iso 13485
Quality System
Pharmaceutical Industry
Cross Functional Team Leadership
Fda
Lean Manufacturing
Sterilization
Process Improvement
Validation
Quality Auditing
Quality Assurance
Regulatory Affairs
Management
Capa
Quality Management
Gmp
Team Building
Internal Audit
Strategic Planning
Leadership
Fda Gmp
Microsoft Office
Training
Iso Standards
Manufacturing
Root Cause Analysis
Business Process Improvement
Corrective and Preventive Action
Regulatory Submissions
Environmental Monitoring
Microsoft Word
Auditing
Documentation
Supplier Quality
Quality Control
Osha
Epa
Establishment Registration and Listings
Drug Establishment Registrations
Iso 9001
21 Cfr Part 11
21 Cfr
Calibrations
Udi
Healthcare
Team Leadership
Prop 65
Standard Operating Procedure
Iso 13485
Quality System
Pharmaceutical Industry
Cross Functional Team Leadership
Fda
Lean Manufacturing
Sterilization
Process Improvement
Validation
Quality Auditing
Quality Assurance
Regulatory Affairs
Management
Capa
Quality Management
Gmp
Team Building
Internal Audit
Strategic Planning
Leadership
Fda Gmp
Microsoft Office
Training
Iso Standards
Manufacturing
Root Cause Analysis
Business Process Improvement
Corrective and Preventive Action
Regulatory Submissions
Environmental Monitoring
Microsoft Word
Auditing
Documentation
Supplier Quality
Quality Control
Osha
Epa
Establishment Registration and Listings
Drug Establishment Registrations
Iso 9001
21 Cfr Part 11
21 Cfr
Calibrations
Udi
Healthcare
Team Leadership
Prop 65
Standard Operating Procedure
Certifications:
Iso 13485 Quality Management Systems Auditor

Stephana Biggins Jacksonville, FL
View pageWork:
PSS World Medical
2010 to 2000
QA Regulatory Manager
Microtek Medical
2009 to 2010
Sterilization Validation Supervisor
Biomet Microfixation
2002 to 2009
Regulatory Compliance Specialist
2010 to 2000
QA Regulatory Manager
Microtek Medical
2009 to 2010
Sterilization Validation Supervisor
Biomet Microfixation
2002 to 2009
Regulatory Compliance Specialist
Education:
Columbia Southern University
2012
B.S.
Jones College
2002
A.S. in Medical Assistant
Jones College
1989
Diploma in Medical Assisting
2012
B.S.
Jones College
2002
A.S. in Medical Assistant
Jones College
1989
Diploma in Medical Assisting