Quality Assurance Manager
Resume:
RESUME
Terry Reid
Crystal Lake, Il 60012
815-***-**** cell
*********@***.***
My Philosophy is very simple. Think of ways to create value for
the organization above and beyond your job description.
EXPERIENCE
TC Reid Consulting
2004 - 2010
Business owner
Sage Products
Cary, Il
Director Quality Assurance and Regulatory Affairs
2001-2004
- Responsible for 2.4 million dollar QA/RA budget. This included
everyday responsibility for the following departments. QA, RA,
Validation, Analytical Lab Services, Microbiology and Supplier
Quality.
Accomplishments
- Developed and implemented corporate wide plan transitioning a
primarily class 3 medical device company into primarily a solutions
and OTC monogram drug company.
This included establishing compliance to a new set of fda standards
that included Validation of Drug batching operations, automated
assembly operations, cleaning, and packaging. The fda manufacturing
compliance audit was passed on time to launch a new drug product.
- Shifted 80% of QC responsibility from the quality organization to
manufacturing thus reducing overall labor and shifting responsibility of
quality to the source.
- Regulatory Affairs working in tandem with R&D developed and executed
a plan for submission of the company's first NDA.
FDA NDA approval received on schedule.
Quality Assurance and Validation Manager
1997-2001
- Primary responsibility: establish and manage validation program for
class 3 medical devices.
- QA responsibilities: implement and manage spc program for injection
molding.
Accomplishments:
Reduced injection molding times thus increasing efficiency and yield
above established goals. Cost savings: 1.3 million dollars per year.
Program paid for itself in less than 2 months.
Courtesy Corporation
QA Manager
1995-1997
Primary Responsibility: Work with medical device and pharmaceutical
contract companies in the management of their QC/QA requirements.
Wesley Jessen Corporation/Division of Schering Plough
1982-1995
Started out as an entry level lab technician. Final position was QA/QC
manager.
Education:
BS - Biology - 1982
Illinois State University
Contact this candidate