Technician Quality Assurance
Resume:
Ann McLeod
**** ***** ***** ***. **, Sanford, N.C. 27330
***************@*****.***
Objective: Highly motivated individual seeking a position where I would be able to use my
practical experience and education within the pharmaceutical environment.
Summary:
cGMP experience
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Knowledge of the sterilization process for materials and equipment used in aseptic
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manufacturing.
Excellent documentation skills
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Good background in assembling production equipment and printed materials
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Experienced in Operating Heavy Machinery
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Education:
Central Carolina Community College 2010
Certificate in Bioprocess Technology (2010)
Central Carolina Community College
Associate of Arts in Bioprocess Technology
Completed one year toward this degree
Employment History:
Manufacturing Associate,
Polyzen/TRC April 2014-July 2014
Apex, N. C.
• Inspected film printed for urine bags
• Weight printed films on scale for counted bags
• Documented on batch record counted films and rejects
• Separated natural and white films for print
• Cleaned up any mistakes on printed films with cleaner
• Packaged urine bags for shipment
• Die cut film for print urine bags
• Operated seal urine bags for die cut and inspection
• Prime ports and rings for port bonding
• Washed ports and rings for sanitizing
• Documented ports on record
Process Technician,
Moen/Insource September 2012 April 2013
Sanford, N.C.
Rack faucets parts to be process for coating
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SAP faucets parts into PC
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Count parts and scan bar codes to print labels for storage on shelves
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SAP parts for new PP parts for labels manually
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Fill out scrap tickets for damaged parts
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Transfer parts to different location when needed
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Unrack parts when needed to release for breaks
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Clean area daily
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Process Technician,
bioMerieux/Adecco September 2011-December 2011
Durham, N.C.
Set up the scales, LES and AP machines, also LES Ratio for production
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Performed inspections, detected malfunctions on LES and AP machines
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Completed all production related documentation as required
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Used PC for production of LES and AP; LES Ratio fill check; alone with tare weigh of
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bottles
Make all knowledge of LES and AP machines are purged if necessary.
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Ensue all safety equipment is in place and following all lock out/tag out requirements
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Answer alarms, ensuring that the products meet all quality specifications of the BacT/Alert
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in manufacturing
Responsible for clean up of area including sweeping, mopping, clean up of machines
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and/or around machines, tables
Ensure material feed system working properly and be able to troubleshoot any problems
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Communicated and document with maintenance on all maintenance issues
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Communicate with the team leader, senior process technician about schedule, the
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schedule board for specific requirements or priories for processing
• Communicated with previous process technician to discuss any problems or requirements
from the previous shift. Also communicated with the next shifts’ process technicians.
Manufacturing Associate,
Catalent/Adecco December 2007 September 2008
Morrisville, N.C.
Help with set up, adjusted and operated packaging equipment
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Performed inspections, detected and rejected defective units on conveyor belt
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Completed all production related documentation as required
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Performed maintenance task instructions, help troubleshooting and repaired manufacturing
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equipment
Assisted Quality Assurance in preparing document control unit filing project packets
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Ensured all the equipment and area maintained an organized and clean state
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Implemented changeover of manufacturing equipment
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Conducted changes to the project packets by adding sample paperwork to packets
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Involved in retrieving these packets for customer review
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Prepared logbooks for GLP
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Manufacturing Associate I,
Biolex/Clinforce June 2007 November 2007
Pittsboro, N.C.
• Performed duties following the guidelines and specifications set for GMP production of
pharmaceuticals and therapeutics
Executed SOPs designed for the harvest and recovery of protein extracted from a plant
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based system
Performed affinity chromatography protein purification utilizing the GE Healthcare AKTA
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Explore System
Performed ultra filtrations on batch purifications of final product.
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Maintained proper aseptic technique when performing cell culture within the laminar flow
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hood
Bioprocessing Technician,
Wyeth Biotech April 2005 February 2006
Sanford, N.C.
Performed calibration checks to ensure quality performance of equipment
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Performed chromatography column set up and operations
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Performed batch operations and Clean in Place (CIP) operations
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Procured WFI and steamed WFI drops
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Weighed, measured and checked raw materials for in process products to ensure batches
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Helped with validating processed and equipment
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Maintained records for clean room environment
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Identified and reported process deviations or other issues
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Aseptically collected in process samples from the fermentor
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Assembled and disassembled filtration lines.
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Completed manual bubble point integrity test of hydrophilic filters with WFI
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Assembled CIP portable pressure tanks
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Connected Production Diafiltration Pump (PDP) pump and cunos
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Performed changeover protocols
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Conducted transfers of material air quality
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Performed facility cleaning, including cleaning of equipment such as the laminar air flow
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hoods, biosafety cabinets
Autoco Technician,
Parkdale October 2003 August 2004
Sanford, N.C.
Repaired piecers
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Changed motors and machinery components
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Performed upkeep of frames
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Performed changeover of line equipment
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Sized the materials
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Ensured draft cutting was correct
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Section Fixer,
National Textiles June 1989 February 2001
Sanford, N.C.
• Repaired doffers, piecers, starter stations
Changed motors, and belts
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Provided troubleshooting for electrical components
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Assisted the overhaulers in reworking yarn frames
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Helped repair machinery in connection with production frames
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Maintained assigned frames
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Spun materials in production of goods
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Ran sample packages for lab testing to ensure quality
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