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DARRYL R.

PRATER
2235 Willowview Drive Indianapolis, IN 46239 (317) 354-1644 dp655196@westpost.ne
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SYSTEMS VALIDATION ANALYST
Instrumentation / Systems Analyst / Compliance / R&D / QA-QC / Clinical Trials /
Training
Mass Spectrometry / Metrology / E-Learning / Automation / Technology / IT Liaiso
n / FDA
A seasoned and broad-based systems analyst and validation engineer, I am especia
lly well qualified in instrumentation and compliance. I have managed qualificati
on and validation of instrumentation for R&D and manufacturing projects, providi
ng superior service to internal and external clients.
I am proficient in working closely with development teams and subcontractors. Ha
ving led design, development and implementation of small and large projects, I e
nsure quality and FDA compliance, to allow for release of new products and impro
ved profitability.
q Ensuring FDA compliance for all R&D and manufacturing projects
q Establishing pharmaceutical compliance standards
q Leading and training end-users and development teams on complex instrumentatio
n & systems
q Liaising with internal and external contractors for complicated safety regulat
ions
My experience is supported with a BS in Chemistry from Fisk University. Addition
ally, I have augmented my education with coursework in IQ/OQ Training, Technical
Writing and Compliance for Electronic Records Integrity. Colleagues have descri
bed me as an excellent trainer with exceptional people skills.
SELECTED ACCOMPLISHMENTS
Integrated Eli Lilly department in wake of transfer. Tasked with assessing compl
iance for Eli Lilly with newly merged department, reviewed documentation to iden
tify contract work that might be done internally. Realized all work could be bro
ught in-house, saving $600K and ensuring compliance.
Prepared departments world-wide to stay FDA compliant. FDA made a surprise inspe
ction in another department of Eli Lilly discovering a deficiency with similar e
quipment. Led large remediation effort. Orchestrated implementation world-wide t
o 20 sites. Attained compliance and set-up systems to prevent future issues.
Managed relocation of department to new building. Acted a liaison between contra
ctors building new research building, for Pharmacia, and the transfer of analyti
cal equipment to new facility with no risk. Initiated new safety requirements pr
eventing losses of an estimated $400K.
Established safety and compliance. A new opportunity was available for transfer
of department into new facility for Pharmacia. Tasked with all issues related t
o building safety and solutions to construction problems. Dealt with all issues
during, and six months after, completion. Exceeded expectations for compliance.
CAREER HISTORY
Sr. IT Analyst / Validation Coordinator, Eli Lilly & Company, 2003 to 2010. <$1B
pharmaceutical manufacturing firm. Supported compliance for operations laborato
ry service group for FDA regulations for 21 CFE part II systems. Ensured inspect
ion readiness for all systems. Led staff of five.
Instrument / Computer Specialist / Chemical Process R&D, Pfizer Pharmacia (Form
erly GD Searle), 2000 to 2003. R&D division of $50B pharmaceutical company. Impl
emented, trained and led systems integration for all analytical instrumentation.
Trained new technology sub-team.
Metrology Liaison, GD Searle (bought out by Pfizer), 1998 to 2000. Calibrated in
struments within analysis group. Testing, training and implementation of qualifi
cation and validation.
Earlier: Process Analytical Chemist, GD Searle, Quality Control Analytical Chemi
st, NutraSweet Company.
Personal: I enjoy photography, traveling, reading, music appreciation and involv
ement in community activities. I am also a member of the American Chemical Socie
ty, holding various elected positions.

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