J. Scott Arnott Email & Phone Number

-Implement and oversee the Quality Plan for the company-Prioritize Quality Assurance workload as needed/priorities shift-Develop and maintain the Quality Systems necessary for compliance with the FDA cGMPs, and other agencies as necessary-Provide Quality input and oversight to various site construction projects (Inventory Control warehouse, laboratory, and office areas)-Responsible for new hire employee training, employee growth and development/guidance and conducting performance reviews in a timely and objective manner-Lead/host FDA inspections (Pre-License Inspection), Ohio Board of Pharmacy, and other regulatory inspections, as neededCourses / Conferences:-Selection Process and Interview Training with Mix Talent - March 2024

-Responsible for building and leading QA-Operations policy and procedures including authoring new training policies, SOPs, programs for company personnel, assuring compliance with existing policies and procedures.-Provided Quality Assurance oversight and approval to support manufacturing operations and product/testing.-Responsible for overall product lot disposition and release. -Supported QA aspects including: Document Control, Change Control, CAPA, Deviations/Investigations, Audits, Inventories Oversight, or other key function and cross train to support other functions. -Prioritized Quality Assurance workload as needed/priorities shift. -Supported interactions with the FDA and other regulatory agencies, when required. -Responsible for new hire employee training, employee growth and development/guidance and conducting performance reviews in a timely and objective manner.-Responsible for authoring and performing team review/QC review of various Biologics License Application (BLA) sections / modules. Courses / Conferences:-New Manager Training - October 2023 - January 2024-Dichotomy of Leadership - September 2023-American Heart Association-Heartsaver First Aid, CPR, & AED - September 2023-Best Practices in Preparation for an FDA Computer System Audit - August 2023

-Responsible for building and leading QA-Operations policy and procedures including authoring new training policies, SOPs, programs for company personnel, assuring compliance with existing policies and procedures.-Provided Quality Assurance oversight and approval to support manufacturing operations and product/testing.-Responsible for overall product lot disposition and release. -Supported QA aspects including: Document Control, Change Control, CAPA, Deviations/Investigations, Audits, Inventories Oversight, or other key function and cross train to support other functions. -Prioritized Quality Assurance workload as needed/priorities shift. -Supported interactions with the FDA and other regulatory agencies, when required. -Responsible for new hire employee training, employee growth and development/guidance and conducting performance reviews in a timely and objective manner.-Responsible for Team Review and QC Review of Biologics License Application (BLA) Modules. Courses / Conferences:-Root Cause Analysis - March 2023-PDA Microbial Data Deviation Investigations Conference - November 2022-Project Management for Non-Project Managers - October 2021Professional Memberships:-Society of Quality Assurance (SQA) - March 2022 - Present -Parenteral Drug Association (PDA) - November 2022 - Present

Cleveland, Ohio, United States

-Worked with the Assay Development and Quality Control departments as the main Quality Assurance representative. Key areas of collaboration included but were not limited to; method and method qualification/validation, process monitoring, inventory control monitoring and environmental monitoring. -Facility Lead for equipment calibration and preventive maintenance program. Responsibilities included: scheduling, equipment database updates, addition of all new equipment, review of calibration certificates, etc. -Department Lead for Deviations/Investigations module of the TrackWise Digital Electronic Quality Management System (eQMS)-Participated and led new hire interviews for inter-departmental as well as cross functional candidates. -Performed lot disposition review and final Quality Assurance release of Drug Product. -Main Quality Assurance representative for all facility related activities included but not limited to, annual shutdown, alarms, preventive maintenance of air handlers, humidifiers, generators, etc.Courses:Risk Management of Raw Materials in an GMP Environment - January 2021

Cleveland, Ohio

-Worked with the Assay Development and Quality Control departments as the main Quality Assurance representative. Key areas of collaboration included but was not limited to; method and method qualification/validation, process monitoring, inventory control monitoring and environmental monitoring. -Facility Lead for equipment calibration and preventive maintenance program. Responsibilities included: scheduling, equipment database updates, addition of all new equipment, review of calibration certificates, etc. -Coordinated and facilitated QA-related production and production-related activities.-Controlled document life cycle activities, including biennial review of procedures and document retention utilizing TrackWise Digital's Electronic Quality Management System (eQMS). -Processed document control requests and issued controlled forms, logbooks, notebooks, master production records, and protocols.-Reviewed batch-related documentation and ensured resolution of issues to release product.-Ensured that products were manufactured in compliance with regulatory and cGMP guidelines.-Compiled and verified all batch-related documents into a final product lot disposition package.-Communicated lot disposition pending issues to management.-Gathered metric information for use in continuous improvement of areas of responsibility. Reported to management as needed.

West Jefferson, Ohio

Worked at the Battelle Biomedical Research Center which focuses on highly infectious diseases as well as chemical/biological agents in Biosafety Level (BSL) 2 and 3 containment laboratories. As a contract research organization (CRO), I helped Battelle to serve US and EU government clients as well as various US commercial clients. -Review draft protocols and attend meetings with key staff-Compile study, validation, and qualification records and paperwork, as well as facility and equipment records -Review records for technical content, data accuracy, as well as, appropriate regulatory, protocol, and Standard operating procedure (SOP) compliance for GLP and non-GLP studies-Review data summary tables against raw data for accuracy-Work directly with technical staff and management to resolve issues and help coordinate the correction of errors -Assist Study Directors in responding to Quality Assurance Unit audit findings-Review final report for protocol and SOP compliance while ensuring that the report accurately reflects the raw data-Perform external, on-site audits of raw data and final report to ensure compliance with protocol, SOP, and federal regulations at BSL-4 laboratory in San Antonio, TX-Maintain U.S. Department of Defense (DoD) Secret Level Security Clearance March 2017 - June 2019Awards:Outstanding Performance Award - January 2019Outstanding Performance Award - August 2018Outstanding Performance Award - June 2018Outstanding Performance Award - July 2017Outstanding Performance Award - July 2017Staff Appreciation Award - May 2017Courses:Good Laboratory Practices (GLP) for Study Directors - June 2018Professional Memberships:Society of Quality Assurance (SQA) - May 2016 - July 2019

Sidney, Ohio

-Conducted routine quantitative and qualitative inspections on raw materials, in-process materials, finished products, processes, equipment, and environment-Ensured analytical equipment function; preformed checks; calibrations; and standard maintenance on Karl Fisher acid and salt titration machines, pH probes, Brookfield viscometers, color meters, water activity machines, and NMR moisture and fat machines-Prepared reports and customer facing documents

Groveport, Ohio

-Operated electrofishing equipment on a daily basis in various streams and rivers across the state of Ohio-Made connections between the types of fish caught and the overall water quality of collection sites.-Responsible for upkeep and maintenance of truck, boat, trailer, and all other electrofishing gear, equipment, and tools.-Accurately explained the electrofishing process to land owners in order to ask and gain permission to use private land as a way to access a launch site. -Shocked and collected fish using boat, roller beast, and longline methods. -Identified and recorded all species types as well as weights and lengths. -Gained fish filleting skills needed for fish tissue lab studies relating to Ohio game fish.-Responsible for the safe release of all fish caught after necessary data was collected. -Familiar with the use of GPS and topographic maps in order to find launch sites as well as multiple collection locations per site.-Entered fish and water quality data into Ohio EPA databases.-Gained Adult First Aid/CPR/AED certification as well as a lifetime Ohio boating license.

Columbus, Ohio

-Facilitated improvements of the recycling program by conducting research based on other local universities -Frequent communications with ODU facilities and maintenance personnel to gain supplies needed as well as to supervise the overall improvement of the program-Responsible for hiring and managing three work-study students -Maintained all recycling bins on campus by emptying and cleaning areas each week

Columbus, Ohio

-Prepared daily lab experiments for all lab classes in the Department of Natural Science-Prepared chemical and biological solutions as well as agar plates, slants, and broths-Used fishing seines and nets, mist nets, and small and large mammal traps-Care and maintenance of campus greenhouse and aquaponic system-Use and care of cadavers-Experienced in taxidermy/specimen preparation

Bachelor'S Degree, Biology

Activities and Societies: St. Albert Society; Ornithology Birding Club Clubs/Organizations: St. Albert Society (ODU Science Club) ODU.

Bachelor'S Degree, Environmental Science

Activities and Societies: Green Panthers Awards: -Outstanding Environmental Science Student of the Year - 2014