Heidi Busz

  • Warsaw IN

RA/CA Graduate with Microbiological Laboratory Experience

Summary

Experienced laboratory technician with more than four years of biotech/medical device experience in regulated environments. Professional expertise includes microbiological testing, executing validation studies, and sample management. Actively seeking employment opportunities beyond bench work that are geared toward regulatory affairs and/or clinical research in order to utilize academic and professional experience while staying at the forefront of scientific innovation.

Work History

Work History
Sep 2013 - Present

Microbiology Laboratory Technician II

Zimmer Biomet
Utilize expertise in microbiological testing to support Sterilization Technology, Quality, and Product Surveillance departments to assure sterility of pre- and post-market products and to closely monitor effectiveness of current biologic upgrade processes. Work closely with Advanced Technology and NPD departments to test and define sterilization measures for 510(k) submissions and perform durability testing. Responsible for investigational troubleshooting, inventory control, and training of new microbiology technicians. Responsible for operation, maintenance, and calibration of laboratory instrumentation. Execute validation studies for the development of sterilization protocols.   Presentation of environmental, microbiological, and sterilization data trending. 
Jun 2013 - Mar 2014

Independent Distributor

Self-Employed
Direct sales for multi-level marketing company.
Aug 2011 - Sep 2013

Financial Advisor/Construction Laborer

D&B Holdings LLC
Prepare financial and court documents. Create detailed transaction histories using Excel. Use knowledge of materials, methods, and tools to complete construction and/or repair of residential buildings. Knowledgeable of safe work practices, including safety precautions for operating power equipment. Perform work involving prolonged periods of standing, stooping, reaching, crawling and climbing.
Aug 2011 - Sep 2013

Child Care Provider

Self-Employed
Provide both in-home and drop-off child care services with a 24/7 availability.
Jun 2010 - Jan 2011

Server

Maggiano's Little Italy
Serve patrons in a fast-paced environment in a friendly and efficient manner. Accurately record orders and partner with team members to serve food and beverage that exceeds guests' expectations.  Answer patron inquiries and resolve issues promptly.  
Oct 2008 - Apr 2010

Operations Technician

Tilson H.R./BioStorage Technologies
A progressively responsible role demanding expertise in quality assurance methods, business continuity measures, and over 135 Standard Operating Procedures to ensure total regulatory compliance. Daily exposure and handling of hazardous, infectious and/or toxic materials, and a strong working experience with MSDS, universal blood-borne pathogens, and risk management. Valuable quality/regulatory experience in quarterly and annual internal audits to ensure that all operating procedures were reliable and sound, external audits performed by clients and the FDA, document control, automated workflows, as well as reporting/managing deviations, complaints, and change control requests. Receive, handle, process, validate, store, and retrieve irreplaceable biological and production samples in a cGxP environment (GTP, GCP, GMP, GSP, and GLP). Maintain the integrity of the samples while ensuring quality execution of Specimen Management policies and procedures. Pledge to provide exceptional customer service. Work closely with other staff in the department and management to conceive and define services based on customer needs and requirements.

Education

Education
2014 - 2015

Master of Science, Orthopedic Regulatory and Clinical Affairs

Grace College

Coursework in Orthopaedic Foundations, Orthopaedic Anatomy and Physiology, Introduction to Medical Device Law, Writing for Regulatory and Clinical Affairs, Clinical Trial Management, Good Clinical Practices, Acquiring and Managing Clinical Data, Clinical Trial Monitoring and Auditing, Regulation of Medical Devices:  Submissions, Regulation of Medical Devices:  Compliance, Global Medical Device Regulation, Project Planning for the Medical Device Industry.

2013 - 2013

Post-Baccalaureate Continued Education

Indiana University of South Bend
Coursework in Medical Terminology and Personal Health and Wellness.
2004 - 2007

Bachelor of Science, Biology

Indiana University of Bloomington

Coursework in Molecular Biology, Organic Chemistry, Genetics, Biochemistry, Medical Sciences, and Mycology.

Skills

Skills

Microbiology Techniques

Bioburden Testing; Bioburden % Recovery; Sterility Testing Bacteriostasis/Fungistasis; Bacterial Endotoxin Testing (kinetic turbidimetric; Heterotrophic Plate Counts; Microbial Identification Studies and Genome Sequencing; Decontamination/Disinfection/Sterilization/Sanitization Procedures; Media Preparation; Growth Promotions (quality control); Durability Testing

Genetic Experimentation Techniques

Genetic analysis of Drosophila melanogaster, Escherichia coli, and Saccharomyces cerevisae

Mutant searches; Analysis of linkage; Determination of allelism or complementation; Fine structure mapping within genes

Mycology Techniques

Environmental sampling; Fungal culturing; Microscopy techniques and stains; Identification

 Molecular Biology     Techniques

DNA and RNA Isolation and Purification; Nucleic Acid Hybridization; DNA Transfer/Northern Transfer and Hybridization; DNA Cloning and Sequencing and PCR Analysis

Organic Chemistry     Techniques

Extraction; Filtration; Recrystallization; Sublimation; Centrifugation; Distillation; Chromatography; Electrophoresis

Accomplishments

Chosen by BioStorage Technologies management to assist the expert cold chain logistics team by receiving inbound shipments at the Indianapolis facility, preparing outbound shipments, as well as traveling internationally for transfers of large shipments of biological samples (~200,000) from European sites to the facility in Darmstadt, Germany.

Selected from the BioStorage Technologies Operations team to:  work in small teams to create, test, and validate new versions of the web-based inventory storage system with IT follow-up and issue resolution; work with upper management and various departments to define new services, processes, and positions; and work individually on client-specific projects.

Chosen by Zimmer Biomet Microbiology management to independently perform annual qualifications on two separate in-house steam sterilizers.