CHARLES ODERINDE.

3207 Acklen Dr SW
coc924d2@westpost.net
Apt # D28 Huntsville AL 35805
(256)4795636

Objective: Quality Assurance and Regulatory Affairs position in a biotechnology,

Pharmaceutical or medical device company focusing on quality control and regula
tory affairs.
Highlight of Qualifications
Extensive knowledge of quality assurance,
In-depth knowledge of ICH GCP guidelines,
GMP, GCP, GLP
Extensive ICH GCP training,
Control of Pharmaceutical Products including Product Testing,
A self-motivated, resourceful and diligent individual with strong analytical, in
vestigative, problem solving, decision making, organizational, communication and
interpersonal skills.
Experience: Kriger Research Center Inc. Canada
Quality Assurance Officer
Experience in application of GMP, ICH, FDA and TPD guidelines in relation to qua
lity issues.
Generated audit and non-conformance reports for in-line and in-process tests in
both manufacturing and laboratory settings.
Method Development and Validation
Developed and validated analytical methods
Performed process optimization and validation
Performed cleaning validation on manufacturing equipment
Documentation
Prepared protocols, SOP's and other technical documents in accordance to in-hou
se, compendial and regulatory requirements.
Compliance Auditor
Prepared the audits of the QC lab with a primary focus on reviewing laboratory r
ecords. Generated laboratory report patterns outlining observations and suggesti
ons for corrective actions.
QA Documentation Associate
Generated a raw material specification and a f
inished product specification for Product rhEGF which will be supplied to the US
A,
Formulary Consultant and Technical Writer
Compiled concise report outlining the drug submission req
uirements of all Canadian provinces
Compose
d a detailed SOP detailing the use an Analytical balance.
QA Trainer
Provided an orientation session for n
ew employees describing the pharmaceutical manufacturing environment.
Created a flow chart outlining the processes and cri
tical controls involved in a pharmaceutical environment, from the time raw mater
ials are received, to the manufacture of the product, and the shipping of the fi
nished packaged product to consumers for use applying the knowledge of GMP, GLP
and GCP
Matsu Alabama Inc., Huntsville AL
 2006 - 2010
Quality Auditor
* Ensure that all Quality engineering processes for new product planning report
(NPPR) milestones are met
* Maintaining product integrity by ensuring parts provided to manufacturing met
quality standard for engineering specifications, ISO 9001/2000, TS16949 and Six
Sigma standards
* Create advanced product quality planning (APQP) requirements, including but no
t limited to, process failure mode cause and effect analysis (PFMEA), Process Fl
ow Charts, and Process Design Sheets
* Working experience of SPC, JIT and lean manufacturing
* Applying DMAIC methodology in solving quality related issues
* Direct interface with customers and suppliers in resolving quality issues
* Ensure that process engineering is aware of any new processes needed to suppor
t new product launch requirements
* Using 8D and 5WHY quality technique in resolving customer quality issues
* Performing internal and external audit
* Supervising teams of quality inspectors and evaluating their daily performance
* Provide process data to verify capability of critical characteristics prior to
high volume trials
* Communicate within manufacturing engineer, any technical developments that may
aid in increasing productivity, reducing scrap, or providing ergonomic improvem
ent to any existing process
* Lead continuous improvement activities necessary to reduce machine downtime, r
educe scrap, and increase productivity

West Wind Technologies, Huntsville, AL

2005-2006
Quality Control Technician.
* Created and reviewed process, installation and instructions for accuracy
* Use engineering drawings and blue prints to perform inspections
* Ensured information placed on drawing was accurate and functional in accordanc
e with system requirement
* Interpreted customer specifications
* Performed receiving, in process and final inspections on electronic circuit bo
ards
* Maintained and calibrated hand inspection tools and fixtures
* Performed continuity test, bonding test and checked torque on complex mechanic
al and electrical assemblies
* Knowledge of AS9100 Quality Management System Requirements
* Deep knowledge of quality procedures and First Article inspections
* Working knowledge of ISO 9001-2000 and JIT
* Use of different measuring devices, e.g. (calipers, micrometers, protractors,
height gauge, dept gauge, pin gauge, multi-meter etc.)
* Use of government requirement standard e.g. (IPC-A-610B, IPC/EIA-J-STD 001, IS
O 90001: 2000 etc)
EDUCATION
Kriger Research Center Inc. Canada
QUALITY ASSURANCE & REGULATORY AFFAIRS May 2010
ICH, GLP, GCP, GMP GUIDELINES PROGRAM
Alabama A&M University, Normal, AL
M.S Industrial Technology May 2008
GPA: 3.41/4.0
Federal University of Technology Akure. Nigeria
B.S, Electrical and Electronics Engineering May 2003
3.47/4.0
HONORS / ACTIVITIES
Technology Department Financial Secretary, 2001-2003.
Deans list, 1998-2002