Luz M. Arcila de Gangemi!
( c ) 862-***-****!
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SUMMARY
Package Machine Operator/warehouse Specialist with extensive experience in high speed packaging of pharmaceuticals. Able to follow OSHA and FDA regulations as well as SOPs and Good Manufacturing Practices (GMP). Hard working, dependable and safety conscious team player who strives for quality and achieves consistent production results.!
Professional Experience
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ImprimisRx / Harrow Inc, Ledgewood Nj Dec 2021- Current
• Visual Inspecter
• Conduct visual inspection of vials in accordance with regulatory agency guidelines
• Visually identifies particles,fibers and other defects in sterile products
• Documents activities in real time on controlled documentation and legibly, per SOP’s and CGMP’s
• Performs component counting and basic math calculations
• Performs cleaning of rooms,tools and equipment
• Performs specific visual inspections per SOP’s
• Ensures product meets appearances specifications before sending the product for packages
• Performs bulk packaging for product vials for shipment to another facility
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Mondelez International, Fair Lawn NJ 2013-2021
• Utility/Machine operator in which responsibilities include to get all components for baggers foil or plastic from stock and issue these components out of inventory maintaining an accurate level.
• Operate Cartoner, check for code dates as well as weight to be able to start operating other variety of machinery.
• Also responsible for minor trouble shouting always keeping in mind the safety as the number one priority for all the staff around,practicing OSHA regulations such as log out- tag out .
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BIOMET, Parsippany NJ 2007-2012
Pulled components and raw materials from inventory and issued them to production lines. Received parts into stock. Maintained all safety and housekeeping procedures. Documented transactions accurately following FDA guidelines. Maintain data entry on inventory software .
• Performed warehouse cycle counts using Agile hardware program and other documentation forms .
• Followed all FDA and OSHA procedures while maintaining high production rate .
• Recognized for ability to get necessary parts to production floor efficiently.
• Selected to train new staff ensuring compliance. ABBOTT LABORATORIES, Whippany NJ 2006-2007
Picker /Packer
Check material into and out of the packaging module according to blue prints and FDA regulations. Inspected products for quality and completed documentation.
• Conducted training of fellow colleagues to operate packaging equipment.
• Recognized for excellent attendance record.
P F I Z E R, I N C . P a r s i p p a n y N J
2002-2006
Machine Operator /Packaging Department
Assembled packaging components according to instruction .Operated filling, capping,labeling,and cartooning equipment on solid dosage,oinment and cream,liquid and aseptic packaging lines .set-up equipment .
• Performed in-process quality inspections .
• Conducted training of new employees.
• Assisted with the material accountability and reconciliation process.
• Reviewed standard operating procedures and made recommendations for revision.
• Earned certified OJT Trainer status.
EDUCATION
County College of Morris, Randolph,NJ English as a second language. Morris County Vo- Tech,Denville NJ-Medical Terminology course. Diploma,La Anunciacion,High School,Medellin, Colombia .
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