Deborah A. Krauth
East Windsor,NJ
Summary
Highly experienced IACUC Coordinator with extensive knowledge in several in-vivo areas of GLP and non-GLP Preclinical Research, this includes development of medical devices, toxicology, and surgical research. Knowledgeable in the FDA (40 CFR Part 160), AAALAC, USDA (AWA), and OLAW (The Guide for Care and Use of Laboratory Animals) regulations. Extensive understanding of responsibilities beyond the requirements of the job description which includes training, committee membership, multi-site assistance, and supplier audits. Seeking opportunity to use my unique combination of a QA Auditor, Study Coordinator and IACUC Coordinator to work closely and confidently with clients to build protocols that efficiently meet their preclincial needs towards FDA submissions.
Overview
26
26
years of professional experience
Work History
IACUC Coordinator II
LABCORP (Early Development)
Bedford, MA & Somerset, NJ
09.2023 - Current
- Responsible for coordinating the function of the Institutional Animal Care and Use Committee (IACUC), reporting activities to the Institutional Official, and working closely with the IACUC Chair, Study Directors, Project Managers, and Research Associates.
- Responsible for assisting the IACUC Chair by setting agendas, providing all accompanying paperwork for meetings and distributed to IACUC members in a timely fashion, in charge of the IACUC Committee approval to distribute all IACUC documentation and all meeting related documents. This position also includes hosting an educational component at each meeting.
- Responsible for scheduling, managing, and tracking of Protocol review by DMR’s, VVC’s and organizing/hosting FCR meetings.
- Creation and submission of annual reports for regulators (USDA, OLAW, AAALAC International).
- Conduct training sessions of IACUC duties and animal welfare concepts at multiple Labcorp sites.
- Maintaining compliance with established regulatory guidelines for the care and use of animals in research.
- Participate in supplier site audits, including requesting documents and scheduling.
- Participate in the preparation of two site closures, including continual communication with regulation organization in the field of Laboratory Animal Science and Labcorp management team.
- Contribute to Culture of Care activities.
GLP QA Officer II, III, and IV
LABCORP (Early Development)
Somerset, NJ
09.2020 - 09.2023
- GLP QA Officer IV (November 2022- September 2023)
- GLP QA Officer III (May 2021-November 2022)
- GLP QA Officer II (Sept. 2020-May 2021)
- Inspects procedures, reports, facilities, equipment, and data for on-going and completed toxicology data supporting both clinical and non-clinical studies for adherence to protocols, SOPs, U.S. and International GLP regulations and regulatory guidance documents. Reports to Principal Investigator, Study Director and management on facility and study quality compliance issues.
- Presenter of GLP training. Responsible for training up to 15 new employees in the company monthly and tracking the training records. This responsibility includes being available for GLP related topics on a consistent schedule.
- Established a Data Integrity Training Program that was tailored to meet the unique needs of each department resulting in a significant reduction of Data Integrity related findings.
- Responsible for weekly scheduling of all QAU in process audits (Study and non-study related)
- Member of the IACUC committee (2022-2023)
- Recipient of three awards for my participation in an accelerated timeline for Report submission.
Preclinical Scientist I
ETHICON
Somerville, NJ
01.2019 - 01.2020
- Responsibilities included serving as Study Coordinator for Preclinical surgical device studies (protocol writing, data collection and writing a final report), preparation and scheduling of animal and human cadaveric model laboratories, preparation of laboratory area and ordering cadaveric and animal tissue samples. This position also included reviewing audited reports and correcting the findings in a timely fashion.
- Primary liaison for product submission in Japan. This two-month project included daily contact with the Johnson & Johnson Japanese representative and communicating all findings to our US Study Director. Rapid replies for our Japanese associates, preparation of records, writing of amendments/deviation, resolution of all audit findings, and extreme organization was necessary for this assignment. This project was completed prior to the anticipated deadline.
- Primary liaison for preclinical studies conducted at Contract Research Organizations (CROs). The responsibilities of this role included shipment of study related materials, establishing study schedules, verifying financial responsibility and timely availability of funds, frequent communication with the CRO Study Director, and data review.
- Awarded a "Certificate of Recognition" for extraordinary dedication and flexibility. I was the primary Study Coordinator for a lengthy VOC (Voice of Customer) human cadaver laboratory for model development. This VOC lab included extensive scheduling and communication skills.
Veterinary Technician
TWIN RIVERS ANIMAL HOSPITAL
East Windsor, NJ
01.2007 - 01.2014
- Responsibilities included direct assistance during surgical procedures and office appointments, the preparation and organization of patient information, and the administration of medications. Duties also included maintenance of the O.R. suite, surgical instruments, and surgical equipment.
Technical Writer
PRODUCT SAFETY LABORATORIES
Dayton, NJ
01.2006 - 01.2007
- Responsibilities included writing all final reports for studies done on-site, familiarity with all PSL SOP’s and GLP regulations and proofreading of in-house reports for accuracy against the raw data. This position also included knowledge with the on-site archiving system and retrieval of archived material in a timely manner.
Study Coordinator, Drug Safety Evaluation
SANOFI-AVENTIS PHARMACEUTICALS, INC.
Bridgewater, NJ
01.2000 - 01.2006
- Responsibilities included conducting (initiation through termination) animal studies within the toxicology group. This position involved protocol writing, study planning, scheduling, animal dosing, necropsy, data presentation, and reviewing of GLP and non-GLP toxicology studies. Duties also required proficiency in formulation of liquid and powder compounds and analysis preparation.
- Safety Representative for Drug Safety Evaluation (1997-1999): This position included being the liaison between DSE and the construction company during a multimillion-dollar reconstruction project. The reconstructioned laboratory area was more environmentally friendly, ergonomic and effective.
- SOP Committee Member: Prior to the merger I was responsible for reviewing all In-life SOP’s (1996-2000). During the merger in 2000 I was a member of the Protocol Standardization Committee. My primary role as the author of all SOP’s for In-Life canine procedures was to update them to meet the current industry standards.
- Established, implemented, and maintained the in-house canine procedure training program.
- Primary member of the ordering team: Responsible for ordering all laboratory and toxicology study related supplies with the guarantee that all the necessary supplies were present prior to study initiation.
- Member of the ECG team (2000-2006): This team scheduled and performed all canine ECG’s for toxicology studies. As a primary member of this team, I was responsible for performing the calculations prior to cardiologist review and validation and implementation of the new ECG computer system, Ponmeh Physiology Platform,
- Validation of the Artemis II data collection system
Complete Personal Services
ETHICON, INC.
Somerville, NJ
01.1995
- Responsibilities included the preparation, care and maintenance of surgical instruments, equipment and O.R. Suite. Duties also included placing IV catheters, intubation and surgical preparation of the animals, providing direct assistance to the surgeon in the O.R., administrating and monitoring of anesthesia, maintaining surgical records and providing pre, intra and post-operative nursing care to research animals.
Education
National AALAS, LAT Certification -
01-1998
B.S. - undefined
Clarion University of Pennsylvania
Clarion, PA01-1993
Skills
- Protocol development (GLP, Non-GLP, and IACUC)
- Training of GLP Regulations, Data Integrity, IACUC Introduction and New Member Training, and Preparation for Regulatory Inspections
- knowledge of contributing to successful USDA, FDA, and AALAC Inspections
- Comfortable in animal room settings and with all animal procedures
- Computer skills: Provantis, Microsoft Office, Veeva QMS, Spotfire, Documentum (D2)
Timeline
IACUC Coordinator II
LABCORP (Early Development)
09.2023 - Current
GLP QA Officer II, III, and IV
LABCORP (Early Development)
09.2020 - 09.2023
Preclinical Scientist I
ETHICON
01.2019 - 01.2020
Veterinary Technician
TWIN RIVERS ANIMAL HOSPITAL
01.2007 - 01.2014
Technical Writer
PRODUCT SAFETY LABORATORIES
01.2006 - 01.2007
Study Coordinator, Drug Safety Evaluation
SANOFI-AVENTIS PHARMACEUTICALS, INC.
01.2000 - 01.2006
Complete Personal Services
ETHICON, INC.
01.1995
B.S. - undefined
Clarion University of Pennsylvania