Management Machine Operator
Resume:
Steven Smith
** ****** **. ******, ** ***** Phone: 732-***-**** Email: acg9e0@r.postjobfree.com
SUMMARY
A well-rounded, detailed orientated professional, with extensive experience in the medical field
as a process technician. A team player, innovative thinker, and attentive worker. Areas of
expertise include: QA/QC functions. Processing human bone and tendon grafts, strategy and
planning, managing medical plant facilities, management of multiple complex projects, material
handling, clerical and scheduling duties, and chemical compounding. Strong skills in batch
manufacturing including wet and dry granulation and blending. Highly trained machine operator.
Also some experience with soldering, machine parts, and extensive experience with SAP system.
TRAINING AND CERTIFICATIONS
ISO 9001, class 100 clean room, granulation/blending certification, cGMP, cGLP, MSDS
chemical awareness, SOP, occupational safety, ergonomic safety, PPE, SAP system, data entry,
computer skills, Stand up reach and sit down forklift certification, Level 1 HACCP certification,
SQF, allergens, food defense, document control.
MACHINE EXPERIENCE
Low, medium and high shear mixers, AMF 60 and 100 cubic foot blenders, Corbett
pharmaceutical grade tray dryers, Calibrated balances, Friability testers, Dissolution machines,
HPLC machines, Glassware washers, Autoclaves, Drum lifters
PROFESSIONAL EXPERIENCE
Aurolife/Aurobindo Pharma, Dayton, NJ 01/2014-12/2014
In process Quality Assurance sampler (Contract)
Sampling of all inbound raw materials for testing and retain.
Completion of all associated documentation.
Accepted quality limit (AQL) inspection of all inbound packaging materials.
Applying status tags to approved and/or rejected material.
Review and approval of in process batch record information.
Maintaining cGMP throughout the facility.
Inspection and approval of sampling and dispensing rooms.
Cleaning and maintenance of sampling equipment and calibrated balances.
Review of documentation and comparison of results with manufacturer C of A.
Proper cleaning and sanitation of sampling rooms as per SOP’s.
Writing/updating Standard Operating Procedures.
Assisting management in implementation of new and updated processes.
Assisting management in CAPA investigations where applicable
Promotion in Motion, Somerset, NJ 01/2013-10/2013
Quality Control-Colors and Flavors
Mixing color and flavor solutions for production department.
Coordination with production and planning department to ensure production schedule demands are met.
Management of all subsequent data relating to all raw materials and color and flavor solutions.
Inventory control for all colors and flavors related materials.
Maintaining cGMP throughout the facility.
Cleaning and maintenance of mixing equipment and calibrated balances.
Sampling of materials and comparison of results with manufacturer C of A.
Inspection and evaluation of color solutions and flavor compounds upon return from production dept, to ensure
that the materials meet the required specifications for re-issue.
Writing/updating Standard Operating Procedures.
Assisting management in implementation of new and updated processes.
CorePharma LLC, Middlesex, NJ 06/2011-04/2012
Manufacturing Technician (Granulation)
Following production record to verify issued/staged raw materials.
Proper procedures to ensure safe and timely transfer of staged weighed materials, blended materials, and during
the blending process.
Proper cleaning of blending rooms and equipment per all applicable SOPs.
Operated mixing and milling machines to mix and granulate powdered ingredients preparatory to compressing
into solid dosage tablets.
Reliance Vitamin Company, Somerset, NJ 07/2010-05/2011
Quality Control Evaluator
Physical inspection of bulk product for impurities, anomalies and any defects to determine product disposition.
Preparing and managing retain samples.
Ensuring that all products comply with SOP prior to packaging.
Review of documentation associated with all bulk product.
Weight variation and disintegration testing.
Weekly checks of balances and scales to ensure accuracy.
Providing support to management when performing internal GMP audits.
Periodic checks of final packed bottles to ensure proper seals/documentation.
Temporary contracts: 02/2008-04/2010
International Flavors and Fragrances, Hazlet, NJ
Sample lab stock filler
OHM Laboratories, New Brunswick, NJ
Lab Tech & Dispensing material handler
Neiroda Transport, Somerset, NJ 09/2006-11/2007
Warehouse assistant manager/Inventory control
Responsible for coordination between warehouse and the central office.
Loaded and unloaded, shipped and received inventory.
Conducted reports for Seamen’s and GE ultrasound machines and equipment.
Facilitated in the maintenance and overall appearance and upkeep of warehouse, in accordance with regulatory
standards.
Operated a gas-powered forklift daily.
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