Experience

TriRx Pharmaceutical Services, LLC

• United States
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Quality Assurance Specialist (Formerly Elanco)

  • 2021 - Present

  •Drive successful, thorough, and timely execution of deviation investigations throughout the organization. •Support completion of complex investigations in determining root cause and support identification of appropriate Corrective and Preventative Actions (CAPA) and impact risk assessments. Steer quality improvements with customers, implement effective planning tools, measurement systems and process controls. •Responsible for ensuring compliance to FDA, cGMP standards for Quality Assurance/Control. •Supports Quality Management System (QMS) and the Document Management System (DMS) in a GMP regulated environment. •Engages with diverse cross functional internal team by partnering with Production, Supply Chain, Engineering, QC and QA to ensure investigations are consistently executed and documented. •Interface with Customer Quality Organizations. •Document review and approval, ensuring compliance with regulations, internal procedures, and Quality Agreements. •Investigate product complaints/defects and Suspected Adverse Events (SEAs) for internal and external customers (FDA, USDA, EPA). Show less



Elanco

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Product Surveillance, Animal Health (Formerly Bayer Animal Health)

  • 2020 - 2021

  •Leverage knowledge of FDA and EU Regulatory requirements in investigating product complaints/defects and Suspected Adverse Events (SEAs) for internal and external customers (FDA, USDA, EPA). Work in tandem with Animal Health, Pharmaceuticals, Quality, contract manufacturing and third-party customers in processing, inspecting and analyzing of Regulatory documents pertinent to investigations and audits •Monitor, collect and present data for submission of Annual Product Reviews (APRs) and Product Quality Reviews (PQRs). Collaborate with internal and external customers in maintaining, interpreting and supplying data for their APR’s and PQR’s •Responsible for Retention product – logging, maintaining and examination for APRs. •Responsible for examination and evaluation of returned products for complaints. Show less



Aratana Therapeutics Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Pharmacovigilance Specialist

  • 2014 - 2019

  Aratana Therapeutics, a pet therapeutics company focused on licensing, developing and commercializing innovative biopharmaceutical products for cats, dogs and other companion animals. Aratana means “new beginning” and it defines our mission of developing safe and effective therapeutics for unmet or underserved medical conditions in pets. Our goal is to provide veterinarians and pet owners with new therapeutics that are driven by science and specifically made for pets. •Understand and comply with all Federal regulations regarding the handling and documentation of all Suspected Adverse Events (SEAs), Suspected Lack of Efficacy cases, off label inquiries and product quality (FDA, USDA-APHIS). Articulate scientific information and utilize case management software, classify and document all reportable events according to Federal regulations. •QA review of protocols, data and reports supporting FDA and USDA drug approvals and contribute to safety risk assessments in support of projects/products •Support drafting and review of Safety documents to include study reports, Drug Safety Reports, Risk Evaluation and Management Reports. Assist with preparation of responses to regulatory agency action letters and other requests •Assist in generation/filings for NADAs, DERs, Pharmacy and State Registrations. Participate in US Pharmacovigilance audits and inspections with regulatory agencies •Liaising with Regulatory and Quality teams for ongoing case management, reporting requirements and clinical safety reviews •Demonstrate a strong technical knowledge of Aratana’s products and provide superior customer service •Provide training on pharmacovigilance procedures and processes (pharmacovigilance personnel, training sessions, medical science liaison training sessions, SOP) Show less



Anthem College

• Hospitals and Health Care
• 1 - 100 Employee

• Instructor, Veterinary Technology & Extern/VTNE Coordinator

  • 2012 - 2014

  •Ensure the quality content of instruction for the Veterinary Technology program •Evaluation of training curriculum & participation in the revision, development, maintenance & implementation of existing, new and planned courses •Instruct assigned course(s) in accordance with approved AVMA curriculum •Ensure that classroom atmosphere is conducive to maximize learning & retention of students •Prepare students with the knowledge, skills & work ethic required for future positions in the veterinary community •Institutional Animal Care and Use Committee (IACUC) Chairman •Externship and Veterinary Technician National Exam Coordinator, USDA central contact Show less



Aptuit

• Italy
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• • 2005 - 2006

  •Study Director for GLP pre-clinical pharmaceutical studies. Design, conduct, monitor and report preclinical bioavailability, ADME, and Pharmacokinetic studies. •Coordinate GCP Clinical Phase 1 ADME studies. Protocol generation, data collection, QC & reporting•Accountable for project execution, sales and forecasting the group’s capabilities and capacities•Provide support to the project team including maintenance of documentation, tracking and information retrieval•Serve as a central contact for communications/correspondence with clients on projects•Daily consultation with clients to determine needs and requirements for their final products•Responsible for budget administration and ensuring group runs studies efficiently while maintaining scientific integrity•Consult with clients to determine needs and requirements for regulatory submissions of pharmaceutical products•Utilized Microsoft Office, Documentum systems and client specific software programs to produce and publish regulatory submissions and reports•Member of the Institutional Animal Care and Use Committee Show less

• • 2001 - 2005

  •Coordinate study objectives with outside groups, researchers, vendors and contractors to guarantee on-time completion of study objectives•Generate study protocols, timelines, and study budgets•Schedule and coordinate in-life portion of animal studies and ensure appropriately trained staff is present•Compilation and quality control of raw data, figures, tables, and appendices•Write training SOPs and administer presentations to technical staff•Coordinate internal analysis and tracking of Clinical samples Show less

• • 1999 - 2001

  •Provide technical support in drug development studies•Conduct in-life portion of animal studies, consisting of animal preparation and dosing, surgical procedures, and animal husbandry•Schedule after hours support and sample shipment•Biological sample analysis, radiolabel sample analysis, raw data compilation, and direct correspondence with clients•Train technical staff in animal procedures



Oxford Animal Hospital

• Overland Park, KS

• Registered Veterinary Technician

  • 1998 - 1999

  Specialty Canine Reproduction Hospital Specialty Canine Reproduction Hospital



University of Kansas Medical Center

• Kansas City, KS

• Research Associate

  • 1994 - 1998

  Manged a transgenic mouse colony utilized for embryonic research. Manged a transgenic mouse colony utilized for embryonic research.