QA Assoc EM Coordinator Resume
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Resume:
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QUALIFICATIONS:
COVIDIEN / MALLINCKRODT - Maryland Heights, MO Jan – present
QA ASSOCIATE
• Supervises the Aseptic and Non Aseptic Manufacturing and testing facility of Covidiem/ Mallinckrodt, from an environmental monitoring aspect, to ensure the facility and equipment are functioning under a state of control, with sterile processes remaining within current FDA and EU Aseptic processing guidelines.
• Assists in the development and management of the Environmental Monitoring program for the facility, including but not limited to, SOP development and product and process flow planning to ensure all manufacturing processes are monitored accordingly.
• Partiipates in the planning of routine static and dynamic monitoring for personnel, viable surface, active and passive viable air, temperature, non-viable air particulates, differential pressure, humidity, and WFI systems.
• Collaborates in the creation, training, and implementation of SOP’s and protocols (DOE, IQ, OQ, PQ, and media fills). This includes SOP, and other documentation revisions utilizing the management of change system.
• Supervises the monitoring of the WFI systems to ensure that adequate compliance is maintained from the design evaluation phase through distillation, testing and release for use in conjunction with the Manufacturing and Microbiology departments.
• Evaluates, and participtes in, contamination control functions, facility design, cleanroom classification, and environmental validation of rooms.
• Performs EM trend reports and isolates trending for environmental bioburden trends and remediation of such trends in conformance with approved limits for the areas.
• Conducts environmental non-conformance investigations and other deviation investigations to determine the root cause for non-conformance to a sterile state, or established procedures. This includes using the deviation and CAPA systems to implement corrective actions.
• Experienced with cGMP systems and the CFR, to address quality systems, production batch records and manufacturing requirements to maintain compliance with these guidelines.
• Experienced with QA release functions including batch record review, document control systems, and raw material / finished product sampling, testing, and release.
• Performs employee appraisals, reviews, goal setting, and profiles as outlined in the performance review program.
• Assists in planning, design, stocking and operation of newly constructed laboratories. Performs laboratory compliance and safety audits, along with job hazard analyses, to ensure adherence to cGLP, OSHA, FDA, EU, and NRC regulations and industry standards.
VI-JON LABS, INC. – St. Louis, MO Dec – Jan
MICROBIOLOGIST
• Performed Investigation and participated in remediation of biofilm in water system, including but not limited to, incoming city water, water softening system, RO backflush frequency, chemicals, and technique, UV disinfection of tanks and pipes, inline filtration, frequency and availability of sample ports, and installation of inline sample ports. This included oversight of the installation, and training for use of the new sample ports.
• Conducted independent research into the detection capabilities of two handheld ATP bioluminesce microbial detection systems, to determine the appropriate microbial alert and action levels. Programmed the instruments and validated the system.
• Assisted in resolving issues of tank cleaning, disinfection, and validation of those procedures.
• Implemented appropriate procedures for use of positive controls in microbiology testing including in-house isolates, growth promotion, sterility, preservative effectiveness, time-kill studies, and ATP bioluminescence testing of finished product using the Celsis detection system.
• Established and maintained FDA and OSHA regulatory compliance of laboratory, personnel, methods, and documentation.
• Developed and maintained a secure, comprehensive microbiology laboratory information management system using Microsoft Access with Visual Basic for Applications programming.
• Trained and supervised technicians in CTFA, USP, FDA, and BAM.microbiological methods and procedures for routine testing and organism identification.
• Researched the sustained occurrence, and prevention, of a potential pathogen in an after shave product. Participated in the decision making process that led to the gamma irradiation of one of the raw materials, to eliminate the organism from the finished product.
PILLSBURY CO./ROMONA MANUF. – Spfld, IL/Pahrump, NV Oct – Nov
MICROBIOLOGIST – Food Production / Q.C. SPECIALIST – Nutritional Supplements
• Microbiological analysis, using the BAM and rapid detection methods. with organism identification and serotyping. This includes use of petrifilm, ELISA, fluorescence, MPN and other standard methods.
• Maintained FDA, OSHA, USDA and EPA regulatory compliance of laboratory, personnel, methods and documentation using SPC and HACCP.
• Monitored the frequency of occurrence of E. coli in the flour mill.
• Investigated an increased frequency of Salmonella detection within the facility. This included finding the root source and collaboration with construction workers on the proper replacement and disinfection of the infected concrete on the roof of the building.
• Worked with R & D on the refinement and validation of the ELISA method for detection of Salmonella in raw material and finished product. Traveled to other facilities to train microbiologists in the use of the ELISA for the detection of Salmonella, a well as the use of petrifilm (M) for the detection of pathogens.
• Participated in the development and refinement of Aflatoxin testing of grains and nuts to determine the presence and concentration of mycotoxins produced by yeast and molds.
• routine testing of raw material, and packaging.
• Set up the quality control system for the manufacture of dietary supplements in tablet form. This included the establishment of inventory tracking, Microbiological evaluation of raw material and finished product.
• Supervised microbiological and analytical laboratories.
EDUCATION:
University of Illinois – Springfield, IL
• Master of Science in Biology – Emphasis on Microbial Ecology – May
• Bachelor of Science in Chemistry – May
• Bachelor of Arts in Biology – May
REFERENCES: Available upon request.
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