A Team Extrusion Operator
Resume:
IRA L. HEARNS
Clayton, NC *****
*******@*****.***
EDUCATION & training
Wake Technical Community College Raleigh, NC
Associate in Applied Science: Biopharmaceutical Technology 07/2020 Certificate: Advanced Bioprocess 10/2014
Golden LEAF Biomanufacturing Training and Education Center (BTEC) Raleigh, NC Certificate: Industrial Microbiology 10/2012
Certificate: Bio-manufacturing Science 10/2012
Certificate: Aspects of Aseptic Processing, Level 2 10/2012 Certificate: Elements of Aseptic Processing, Level 1 09/2012 Certificate: Operation in Biotechnology Processes 09/2012 Certificate: Introduction to Biomolecules 08/2012
Certificate: cGMP Biomanufacturing Operations 08/2012 Bio-Work: Processing Technician Training 07/2012
CERTIFICATIONS
Board Certified Process Technician (CPT) 010930 12/2012 WORK EXPERIENCE
Polyzen, Inc. Apex, NC
Production Technician, Level 3 in Casting Extrusion 09/2015-10/2023
● Assist with the validation of equipment or raw material
● Set up and break down all equipment before and after a manufacturing run
● Set up a clean room for a biological product (clean walls, and floors)
● Set all conditions and raw materials to batch record parameters
● Perform all lab tests on raw materials and calibrate all equipment as specified by the batch record
● Follow all cGMP's practices
● Monitor manufacturing processes utilizing a computer control system
● Adhere to safety regulations set by OSHA
● Monitor the quality and specification set by the batch record Hospira Clayton, NC
Production Operator & Label Operator 02/2014-06/2014
● Monitored the process and equipment
● Performed product inspection
● Adhered to SOP’s & cGMPs
Geami Ltd. Hillsborough, NC
Machine Operator 04/2013-06/2014
● Lead and set up for 3rd Shift
● Set up and run converter machines
IRA L. HEARNS
Clayton, NC 27520
*******@*****.***
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WORK EXPERIENCE (Cont’d)
Berk-Tek Fuquay-Varina, NC
Job Title 01/2013-04/2013
● Cabling and extrusion
Papa John’s Garner, NC
Production Team Member, Dough Manufacturing 01/2011-10/2011
● Multi-tasked in food servicing center, producing high-quality pizza dough
● Adhered to policy and procedures working together with team members in the facility
● Monitored equipment while the dough was mixing.
● I have functioned as a Team Leader. Duties included placing dough into clean and well-sanitized trays.
● Adhered to all SOPs & cGMPs
SPARTECH-PEP Newark, NJ 03/1992-03/2008
Quality Control, Extrusion Manufacturing
● Supervised blown Korad film and acetate sheet extrusion lines
● Troubleshoot plastic materials using ISO quality control methods
● Reduced manufacturing costs along with minimizing defeats Production Manufacturing Supervisor
● Responsible for meeting company production expectations and financial abilities
● Sorted raw materials to each extrusion line
● Maintained delivery of final product promptly
● Assisted the plant manager with development and modification issues or requirements
● Inspected equipment to ensure quality standards
CORE COMPETENCIES:
cGMP Proficiency
Standard Operating Procedures (SOP)
Good Documentation Practice (GDP)
Pharmaceutical Quality Control
Research & Development
Analytical Balance Calibration
Statistical Monitoring
Validation
Sterility Testing
Instrumentation
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