Kathleen Mc Carthy
About Kathleen Mc Carthy
Kathleen Mc Carthy is a Clinical Documentation Specialist at Bristol Myers Squibb with over 15 years of experience in document control and management within regulated environments in the pharmaceutical and food industries.
Title and Current Role
Kathleen Mc Carthy currently holds the position of Clinical Documentation Specialist at Bristol Myers Squibb. She operates out of the Summit, New Jersey office in the United States. In this role, she is responsible for ensuring the accuracy and compliance of clinical documentation within the company's regulated environment.
Past Professional Experience
Kathleen has had a robust career with extensive experience in document control and management. Previously, she served as a Document Control Manager at Novartis in East Hanover, New Jersey, where she worked for one year from 2020 to 2021. Before that, she was a Document Control Analyst at B&G Foods, Inc. for four years, from 2016 to 2020. Additionally, Kathleen spent seven years as a Senior Global Document Management Specialist at Bayer in Whippany, NJ, from 2009 to 2016. Her earlier roles include Safety Records Coordinator at Celgene, and Regulatory Affairs Associate at Biomet, among others.
Education and Academic Background
Kathleen Mc Carthy has a solid academic foundation in Environmental Science from William Paterson University of New Jersey, achieving a Bachelor of Arts degree. She also furthered her studies at Fairleigh Dickinson University-Metropolitan Campus. Her educational background has equipped her with the knowledge and skills required for her specialized roles in document management within regulated industries.
Technical Proficiency and Systems Experience
Kathleen is technologically proficient with a variety of software and systems necessary for document control and management. She is skilled in Microsoft Office applications, Adobe Acrobat, and NovStyle. Additionally, she has extensive experience working with multiple document management systems, including CREDI, SubWay Clinical & PreClinical lines, Genesis, TMS, MainSaver, ShareDoc, CONTACT, AGILE, ARISg, and Laboratory Information Management Systems (LIMS).
Quality Assurance and Compliance Experience
Throughout her career, Kathleen has been heavily involved in quality assurance and compliance within document management. She has conducted Quality Assurance reviews of archived records to ensure adherence to company SOPs and cGMP practices. Furthermore, she has provided essential documentation support during FDA audits and audit preparations, reviewing and updating documents for completeness and regulatory compliance.