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Quality Data Entry

Lawrence, Kansas, United States
September 24, 2019

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Breanna Hoffmann -

*** *. ******** **., ********, KS 66044 - 913-***-****

Education University of Kansas, Lawrence, KS

Bachelors of Science in Ecology & Evolutionary Biology, May 2016 Butler Community College, Andover, KS Associate’s in Science, Liberal Arts Major, May 2013

Experience Bayer Animal Health, 12707 Shawnee Mission Pkwy, Shawnee, KS 66216 Full-time contract employee in Quality Assurance, June 2019 – August 2019 Job title: Quality Assurance Compliance Coordinator Duties include providing assurance to management that facilities, equipment, personnel, methods, records, controls, validations, procedures, and practices are in conformance with all applicable regulations, standards and/or specifications. Function includes oversight of audit programs, handling Deviations, Out of Specifications, Complaints, Annual Product Review, Quality Agreement Program, CAPAs and Low Impact Level Events; specifically focusing on investigating, understanding and correcting discrepancies while attempting to prevent their recurrence. TrackWise used daily to manage all remedial corrections to problems, root cause analysis, and preventative actions. Participated in Site Quality Management Review which provides leadership, oversight, and monitors the performance of the Quality System through the review of metrics. SQMR has the authority and responsibility to make decisions and drive implementation of needed improvements required to maintain the quality system. Pfizer Pharmaceuticals, 1776 Centennial Drive, McPherson, KS 67460 Full-time contract employee in Aseptic Quality, January 2019 – May 2019 Job title: Quality Assurance Aseptic Coach/Inspector Duties include working as Quality on the floor in the aseptic area supervising 10-50 operators, supervisors, technicians, etc., hands on coaching operators on proper gowning and aseptic technique. Support for investigations/deviations in conjunction with CAPA. Assures adherence to FDA, EU, DEA, EPA, and MHRA regulatory demands in accordance with c-GMP requirements, specifically compliance with 21 CFR Parts 210 & 211 and Annex 1. Observe Manufacturing media fills and document aseptic behavior as part of the validation package. Support aseptic audit program and positive feedback program for aseptic operators. Supply feedback to Manufacturing Operators, Supervisors, Quality, Engineering, and Validation. Train production with ongoing SOP updates and aseptic techniques based on observations metrics for the month

SunOpta Food Manufacturing,Edwardsville, KS 66111

Job title: Quality Control Food Technician (Auditor), QC Dept. Nov 2018 - Jan 2019 Duties include auditing and supervising all production employees in their daily duties to ensure compliance.Monitoring product quality on a food production line, ensuring critical control point (CCP) is operational. Meet or exceed manufacturing schedules by maintaining proper quality checks. Assist the line machine operators with quality concerns. Monitor specifications of product to ensure accuracy. Perform sensory evaluation of product to ensure quality. Ensure packaging meets production coding requirements. Accurate and timely record of data. Follow all USDA regulations, company GMPs and all food safety programs as they relate to the quality department

IEH Laboratories & Consulting Group, 769 Grant Street, Lawrence, KS 66044 Job title: Quality Control Lab Analyst in MicroBio. Division, Aug 2018 – Nov 2018 Duties include testing clients Finished Product for E. coli, Salmonella, and Listeria using Polymerase Chain Reaction (PCR) through gel-electrophoresis and Aerobic Plate Count incubation for a 24-48-hour turn-around time. Compliance to SOPs including regulatory requirements of the FDA, USDA, and EPA. Continued feedback with QA management. COA creation for customers results. Daily courier pick-up from the client’s facilities using company car. Quality Control measures included Environmental Monitoring & Process Controls. Preparing media, BPW, agarose gels, contact plate films, dilution tubes, & positive/negative controls. Running the autoclave. Proper aseptic technique & behavior

MilliporeSigma, 11296 Renner Blvd, Lenexa, KS 66219 Full-time contract employee in Quality Services, Life Sciences, May 2017 – March 2018 Job title: Inquiry Support, Inquiry Services and Knowledge Management Duties include Traffic Controlling the global Quality Service email inbox, involving the use of Oracle’s RNT, internal network drives, SAP software, Google Apps, Microsoft Office & SharePoint drives. Customer facing role with high-profile clients in the BioPharma industry. Quality & Regulatory direct customer support, helped solve CAPAs & reviewed batch records. Co-wrote & updated Audit Scheduling SOPs. Created a Quality Services training program for new hires. Document creation of TSE/BSE statements, Certificates of Compliance/Conformance, Change Control Notifications, NDAs & CDAs. Validation pulls such as COA, MSDS, Supply Chain Information Requests, Requests for Information, Shelf-Life/Expiry Data, Manufacturing Info, Compendial Grade Data, & Audit File Requests Supervisor: Mike Hampton @ 913-***-**** or Ceva Biomune, 8906 Rosehill Road, Lenexa, KS 66215 Full-time contracted employee in Quality Control Department, August 2016 – Nov 2016 Job title: Quality Control Laboratory Technician I Duties include following Environmental Monitoring SOPs & compliance with all Regulatory requirements pertaining to manufacturing & testing of Quality products. Use sound aseptic technique to eliminate contaminants, follow cGMP, assay tracking and data entry. Create and follow internal test schedules in conjunction with Quality Control, Manufacturing, and Validation. Identify the root cause of out-of-specification results through independent analysis using proper laboratory instrumentation; support CAPAs. Identify specific bacteria/molds using automated lab equipment, & conduct weekly water testing throughout the entire facility

Supervisor: Teri Amyx @ 913-***-**** or KU Biodiversity Institute, 1501 Crestline Drive, Lawrence, KS 66047 Part-time employee working for the Division of Entomology, May 2015 – July 2016 Job title: Research Lab Assistant

Duties include supervising the digitization of specimen drawers for the InvertNet project using an automated machine, working in the collection room, daily use of computer software BugEye & StitchDaemon, data entry of taxonomic names using Google Docs, ordering/sorting specimens, & bar coding/pinning of specimen Supervisor: Dr. Andrew Short @ 785-***-**** or Monarch Watch Non-Profit Organization, 2021 Constant Ave, Lawrence, KS 66047 Part-time employee working for the Kansas Biological Survey, May 2015 – June 2016 Job title: Insect Lab Assistant

Duties include supervising the laboratory and 5 employees of the lab, helping train new employees in laboratory practices, rearing caterpillars, sanitization of laboratory equipment, making artificial diet, microscope use, landscaping, greenhouse labor, packing & shipping of rearing kits, follow SOPs and any regulatory oversight Supervisor: Ann Ryan @ 785-***-**** or

Certificates Introduction to Bio-Manufacturing Certificate (Johnson County Community College) Spring 2016 Honor Roll (University of Kansas), TRIO SES Scholar Award 2013-2016 National Science Foundation S-STEM Scholar for Biodiversity & Renewable Energy Resource 2013-2014 (Scholarship Award)

Research Experience Program Certificate 2016

Global Awareness Certificate – Field Biology in Suriname 2016 Other Talent Project Coordination work including 5S & Lean Management training Member of TRIO Supportive Educational Services 2013-2016 KU Undergraduate Research Symposium participant Fire Extinguisher Training completed in April 2019 Able to type 60 wpm & pass a 2010 version of Microsoft Excel, Word, and Powerpoint References Nancy Vogel – Inquiry Management, Quality Services St. Louis, Missouri - Millipore Sigma, Merck KGaA


Laura Byrd – Inquiry Management, Quality Services

Poole, United Kingdom - MilliporeSigma, Merck KGaA Email:

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