Manager Quality
Resume:
P. Derek Guidry
Church Point, LA 70525
EXPERTISE: Quality and Compliance Management, Operations Management
Summary Demonstrated achiever with exceptional knowledge of plasmapheresis
operations, business practices, FDA, EU, and other regulations.
Internationally HACCP certified
Skilled at learning new concepts quickly, working well under
pressure, and communicating ideas clearly and effectively. Skilled
at diffusing tense situations and bringing resolution to conflict.
Self-motivated and able to work independently.
In 2005 received the only issued Perfect Talecris Inspection Award
(only one of three issued in previous 10 years). Also received
Annual Production Award and Annual Quality Award. (Baton Rouge, LA
Donor Center).
As Regional Quality Manager my centers received numerous awards for
achieving or exceeding production, cost, compliance and development
of staff.
Possess a clear understanding of how Collections, Cost and
Compliance are important to the business and able to accomplish
those goals as an Operations Manager.
Career History & Accomplishments
New Center Development Opening Manager, JUN 2007 - DEC
2009
Training/Operations Manager, NOV 2006 - JUN 2007
Regional Quality Manager, APR 2005 - NOV 2006
Quality Supervisor, JUL 2003 - APR 2005 Baton Rouge,
Louisiana
International BioResources, LLC.
Worked directly with the Director of New Center
Development (unlicensed centers) for IBR, a privately held
provider of Source Plasma in excess of one million liters
per year.
Supervised a team responsible for completing center start
up, which included the monitoring of building construction
(plumbing, phones, IT resources), installation of
equipment, receipt of supplies and organization of center.
Responsible for preparing schedules, progress reports, and
responses to audit findings.
Trained and mentored Center Manager Teams on controlling
inventories, labor cost, hiring staff and Source Plasma
production management.
As the Interim New Center Recruiter, interviewed and hired
all persons within new donor centers (Center Manager,
Assistance Managers, Physician Substitutes, Center
Physicians, and line staff). Responsible for assuring the
new center staffs received the required training within
the needed timeframes. This included finding locations
for trainees and trainers for trainees to train.
As a Regional Quality Manager, I was responsible for
supervision and support of Quality Supervisors at donor
centers with investigations into customer complaints and
issues of non-compliances. Performed corporate review of
all internal incident reports and maintained a database
for tracking and trending purposes. Mentored Quality
Supervisors in daily functions and ensured compliance with
all regulations and working cooperatively with center
operations personnel to achieve common goals.
Extensive experience and familiarity with cGMP, FDA, and
EU requirements.
With the acquisition of the Aventis Donor Centers in July
2003, was regularly and virtually exclusively consulted as
an Aventis SOP Specialist by the Director of Regulatory
Affairs of IBR to assist in the transition. Assisted with
numerous special projects for the Director of Regulatory
Affairs of IBR, in addition to my regular duties as
Quality Supervisor of Baton Rouge, LA donor center.
Quality Supervisor, Aventis BioServices, Inc. SEP 2001 -
JUL 2003 Baton Rouge, Louisiana
Proven success with no 483 ever issued to center under my
direction. No GHA (EU) observations.
Assisted Center Manager with managing, organizing
schedules and monitoring labor cost.
Helped develop and monitor annual budget, supervise
quality control, helped write procedures, arranged and
taught training classes.
Assisted with the purchasing supplies, monitoring
inventories, shipped product and samples.
Served as a training center for the other centers and
trained other designated trainers.
During this time also worked on CAPA teams that were sent
to troubled centers. Would send out an action register of
items identified and perform follow up to assure all items
addressed.
Quality Assurance Manager, Portioned Meats Incorporated.
NOV 1999 - SEP 2001
Assured that the company met and/or exceeded all the
required FDA Quality regulations.
Completed testing on all raw materials received for
Salmonella and E. Coli
Performed pre and post cleanup inspections with FDA to
assure processing plant was deemed suitable before
processing began
Responsible for placing product on hold from shipping, if
needed. Responsible for handling all recalls of products,
if necessary
Educatio B.S. Microbiology
n Louisiana State University
Baton Rouge, Louisiana
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