Machine Operator Process
Resume:
Joseph Baker
Miami fl *****
Residence (305) 655 - 1440
Cellular 786-***-****
BACKGROUND SUMMARY
Result oriented pharmaceuticals operator with extensive experience in Compounding, Quality Assurance and cGMP regulations environment. Comfortable in fast paced environments requiring the ability to multi-task and manage changing priorities without sacrificing attention to details. Ability to work independently or as member of a team Quality oriented individual with reputation to maintain the highest possible quality and productivity.
AREA OF STRENGTH
Sterile Process Manufacturing ● Wet and Dry Compounding ● Cleaning Processes Document Specialist, ● Machine Operator
PROFESSIONAL EXPERIENCES
MAR 2009 – JUN 2016
BD BIOSCIENCES ADVANCED BIOPROCESSING, Miami FL
Process Operator lll / Senior Technician
Staging, compounding of raw materials, milling, blending, process control monitoring and documentation of such procedures for manufacturing cell culture media.
Operates equipments such as but not limited to blenders, mills, mixing tanks, bottle and bag fillers, analytical balances, weigh stations, floor scales and various material handling equipments.
Perform cleaning, inspection, verification for calibration and assist in the maintenance of equipment and facility. Maintains related logs and records and performs equipment troubleshooting.
Partner with validation and qualitative groups on commissioning activities supporting facility startup.
Leads manufacturing daily startup meeting and provides process technical expertise within production.
Setup and operates aseptic liquid filling machine, packaging machine and liquid and powder CIP/ SIP Skid.
Maintains accurate production records, which include operation logs, batch records, bulk container, cleaning logs, tare weight and other pertinent data. KIRK PHARMACEUTICALS, Fort Lauderdale Fl AUG 2008 - JAN - 2009 Machine Operator / Lead Compounder
Clean, setup and operates liquid encapsulation machine and perform and record weight checks during the process.
Weigh and mix various ingredients in liquid encapsulation process and collecting samples for testing.
Ensure the safe handling and operation of equipment and materials used in daily processes.
Maintain and organized a clean work area as per standard operation procedure.
Perform duties as trained and assigned under cGMP regulation. TEVA PHARMACEUTICALS, Miami 1998 - 2008
Process Operator / Lead Compounder
Serve as liaison from Technical Operations to Production in development phase of new and transfer products.
Provide leadership to the compounding/mixing manufacture area under cGMP regulations.
Provide valuable input in the creation of Standard Operating Instructions of fill material manufacturing process.
Perform room, equipment inspection to assure quality of manufacturing processes.
Trained new personal on all compounding SOPs, compounding equipment and techniques.
Review logbooks associated with mixing process to verify compliance with requirements of products to be processed.
Inspect all major equipment for cleanliness and batch record for completeness and accuracy.
Collect in process cleaning and process validation sample.
Coordinate all activities related to process validation, cleaning validation and development studies.
Ensure the safe operation and handling of equipment and materials.
Set up mixing equipment as per Standard Operation Procedures. Two year accomplishments (TEVA Pharmaceuticals) include 1 Author of cleaning procedures for in process equipment 2 Assist in the development of blending procedure of sterile drug product produced by aseptic processing and sterilization.
3 Monitor and maintain compounding area of sterile and non sterile under strict cGMP adherence ensure that records are adequately defined, complete, and archived Performed process simulation using microbiological growth medium LAB FORCE OF AMERICA, Miami Lakes, Florida 1997 - 1998 Manufacturing Operator
Perform cleaning and sterilizing procedures on equipment use to manufacture blood plasma related products.
Maintain an accurate inventory of manufactured Plasma lots and their expiration dating. EDUCATION
High School Diploma
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