Quality Control Customer Service
Resume:
Address Contact
+ *** Moss Ave. + Cell: 816-***-****
+ Liberty, MO + ****.*******@*****.***
J e ff re y W. D u ff
+ 6 4068
Career Summary
An accomplished molecular biologist with over 12 years of pharmaceutical
quality and operational systems experience.
Adept with SOP’s and FDA drug regulations, training personnel, managing
internal and external laboratories. Highly organized and effective
communicator with excellent customer service skills.
Professional Experience
September 2001 – November 2013
Antigen Laboratories, Inc. – Liberty, MO.
Held four positions at this company, each with increasing
responsibilities.
Director of Operations
• Corporate responsibility for Allergenic Extract Manufacturing, Patient
Specific Treatment Set Manufacturing and Allergenic Extract Source
Material Manufacturing.
Skills • Reduced product backorders from near $55,000 to just under $5,000
in six months for a manual manufacturing process by identifying and
• FDA Drug Regulations resolving bottlenecks and re-allocation of labor.
• Directed manufacturing department that observed a 15% increase
• Operations Management
in number of batches produced and 40% increase in total Liters pro-
duced and simultaneously led a facility expansion/renovation project.
• Compounding, Extraction,
and Filtration Techniques • Directed processes for extract and source material manufacturing
ensuring efficient operations and resulting in balanced inventory.
• Sterile Technique
• Ensured operational processes were performed according to SOP,
• Electronic Drug Establishment cGMP and FDA regulations.
Registration, Drug Listing
• Investigated and initiated quality improvements in production
and Structured Product
processes.
Labeling
• Facilities/Contractor Audits Manager, Quality Control
• Primary responsibility of supervising Quality Control laboratories
• ELISA Techniques,
(Microbiology, Chemistry and outside testing via contract laboratories)
Electrophoresis, Radial
to ensure efficient operation.
Immunodiffusion, and
• Ensured Quality Control tests were being performed according
various chemical assays
to SOP and FDA regulations.
• Microbiological Identification
• Represented Quality Control laboratories during inspections
and audits.
• Calibrations/Validations/
Re-certifications • Directed and participated in personnel training.
Address Contact
+ 320 Moss Ave. + Cell: 816-***-****
+ Liberty, MO + ****.*******@*****.***
J e ff re y W. D u ff
+ 6 4068
Professional Experience (continued)
Manager of Quality Control Testing
• Primary responsibility of assigning personnel schedules and performing
product testing including sterility, safety, identity and potency.
• Defined yearly departmental goals and objectives and reviewed outcomes
as a measure of performance.
• Trained new personnel on SOP’s.
Quality Control/Quality Assurance Technician
• Performed all required product testing including sterility, safety, identity
and potency according to SOP’s.
• Inspected and tested drug product containers/closures, extract
components, media and reagents.
• Recorded and reviewed temperature and humidity monitoring for facility.
• Identified environmental/surface/personnel microbiological monitoring
positives.
• Reviewed records.
• Maintained and verified performance of instruments including pipettes,
spectrophotometers, chart recorders and balances.
• Participated in writing and review of SOP’s.
• Participated in deviation investigations.
• Authored, reviewed and performed validations, qualifications,
and re-certifications.
• Maintained testing supply and reagent inventory.
References
Steven Haynes
******.******@***.***
Personal
Ted Odlaug
Education
********@*****.***
Professional
Northwest Missouri State University
Allen Roberson
Bachelor of Science: April 2001
**************@*****.*** Major: Biology with Cellular/Molecular emphasis
Professional Minor: Chemistry
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