STEPHANIE ROGERS
Hamilton,MT
Overview
30
30
years of professional experience
Work History
Senior Quality Assurance Specialist
GSK
02.2012 - Current
Quality Assurance Review Specialist
PUGET SOUND BLOOD CENTER
01.2009 - 01.2012
- The sole Quality Assurance associate for Clinical Services department. This department has five units: the Cell Processing Lab, Hospital Services (Cord Blood), Patients Services (Apheresis unit), Bone Marrow, and Hemophilia.
- Reviews control documents and patient charts
- Trains personnel on regulation and compliance both internal and external
- Reviews and trends deviations, investigations, complaints and adverse reactions
- Performs audits and gap analysis
- Responsible for equipment calibration
- Review validation paperwork for new process and equipment
- Member of the training council
- Quality Representative for LEAN projects associated with Cord Blood and Hemophilia
- Writes, reviews, review SOPs, forms, and other controlled documents
Quality Assurance/Regulatory Affairs Specialist
MEDIQUEST THERAPEUTICS
10.2006 - 11.2008
- Project Coordinator for the NDA- Responsible for the timeline, reviewed all sections, set-up meetings, resolve all issues, and liaison between us and our E-submission provider
- Reviewed Quality Records, Quality Control Data, and Batch Records to release product
- Trained Personnel
- Tracked Deviation Reports
- Perform Audits
- Responsible for Document Control functions
- Prepare, assemble, and archive FDA Submissions both INDs and NDAs
Quality Assurance Associate
MDS Pharma
05.2006 - 08.2006
- Temporary Assignment for Lab temps
- Reviewed study folder for clients
- Tracked Deviation Reports/Maintain the CAPA system
Quality Control Associate III
ZYMOGENETICS
08.2002 - 03.2006
- Played key role in the set-up of Quality Control Department including lab layout, workflow design and equipment set-up. Wrote standard operation procedures, specification, analytical methods and guideline for daily operations for the lab. Interviewed and trained new staff as the lab expanded its team from 2 to 20 people.
- Received the “Wonder Woman” Award Dec 2004 as the most valuable contributor to department operations.
- Responsible for performing analytical testing and general laboratory support
- Quarantine, Test, and Release raw materials
- QC training coordinator
Quality Assurance System Specialist II
FRESENIUS HEMOCARE
10.2000 - 06.2002
- Reviewed Quality Records, Quality Control Data, and Batch Records to release product
- Trained Personnel on ISO and FDA Regulations
Quality Control Analyst/Document Control Specialist
ProCyte Corporation
07.1997 - 09.2000
- Generated, Circulated and Tracked batch records, specification and SOP’s
- Compiled training files and lot files
- Maintained the deviation reports
- Quarantine, Test, and Release raw materials and finished goods (USP testing)
- Responsible for performing analytical testing and general laboratory support
- Coordinated stability testing-Set-up study, pulled samples, analyzed samples, and trended data.
- Member of the Hazmat team
- Wrote SOP’s
In-Process Quality Control Technician
Medeva Corporation
02.1997 - 04.1997
- Short Term Temporary Assignment for Burns Temporary Service
- Inspected samples along production line
Stability Studies Chemist
Bausch and Lomb
03.1996 - 02.1997
- Long Term Temporary Assignment for TAD Temporary Service
- Pulled and analyzed Stability Samples-Trended data
- Packaging Engineering Technician
- Validated new packaging and mfg. equipment
Education
Bachelor of Arts - Chemistry
Goucher College
Baltimore, MD01-1995
Skills
Details
COMMUNITY INVOLVEMENT
Brookside West Condo Association, President, 2006-07, 2008-06, Member-At-Large, Member of Drug Information Association (DIA) 2008-Present
Timeline
Senior Quality Assurance Specialist
GSK
02.2012 - Current
Quality Assurance Review Specialist
PUGET SOUND BLOOD CENTER
01.2009 - 01.2012
Quality Assurance/Regulatory Affairs Specialist
MEDIQUEST THERAPEUTICS
10.2006 - 11.2008
Quality Assurance Associate
MDS Pharma
05.2006 - 08.2006
Quality Control Associate III
ZYMOGENETICS
08.2002 - 03.2006
Quality Assurance System Specialist II
FRESENIUS HEMOCARE
10.2000 - 06.2002
Quality Control Analyst/Document Control Specialist
ProCyte Corporation
07.1997 - 09.2000
In-Process Quality Control Technician
Medeva Corporation
02.1997 - 04.1997
Stability Studies Chemist
Bausch and Lomb
03.1996 - 02.1997
Bachelor of Arts - Chemistry
Goucher College