Kate F. Email & Phone Number

Yonkers, Ny, Us

Congers, New York, United States

Results-driven Quality Systems Analyst with background in cGMP manufacturing and ISO 15378:2017 compliance. Primarily managing change controls, leading internal audits, and ensuring adherence to quality standards. Skilled in document management within a robust quality management system. Collaborative team player adept at facilitating communication, training personnel, and coordinating efforts with site top management for FDA readiness initiatives. Committed to driving continuous improvement and maintaining the highest level of quality assurance in pharmaceutical manufacturing.

Congers, New York, United States

Participated and coordinated implementation of local site Data Integrity project according to 21 CFR Part 11 guidelines by organizing cGMP documentation, coordinating and preparing CSV activities, and training key users and site personnel on Data Integrity principles to maintain best practices.

Congers, New York, United States

Process and issue procedures including SOP’s, specifications, official forms, and pharmaceutical drawings in accordance with current practices, ISO, and cGMP’s. Coordinates information flow between Quality Management System and other Quality systems and departments. Issue and follow up Change Controls and planned deviations. Participates in training and troubleshooting issues for project personnel to use the electronic database and SharePoint. Supervised and works closely with staff to achieve department and company goals. Independently coordinates the movement and management of customer complaint information.

Congers, Ny

Greater New York City Area

• Assisted in marketing and designing advertisement via social media• Maintained social media and brand presence across Twitter, Facebook, and Instagram platforms• Utilized social media and SquareSpace analytics to track user engagement• Assisted in prop production, set dressing, and photographing projects for posts featured on website• Assisted in testing craft projects for companies such as Mattel Inc., Fisher-Price, Bed Bath and Beyond, etc. • Maintained and wrote copy and creatively designed blog posts for craft projects featured on website

California, Md

• Planned and implemented daily lessons to meet age required standards• Supervised children during lunch, outside time and field trips• Maintained a safe and clean facility to meet state guidelines

Towson, Md

• Coordinated university fundraisers and department events• Liason between all university departments to ensure proper communications• Efficiently managed all important telephone calls while also collecting and sorting mail, screening and initiating telephone calls• Maintained daily tasks by arranging meetings and making appointments with individuals on a priority basis• Accountable for organizing confidential files to include social security numbers, birth dates, financial information of all university employees

California, Md

• Supervised staff of 40 and facilities to meet national safety guidelines and county requirements• Coordinated swim lesson program servicing more than 200 swimmers throughout the summer• Supported community events, fundraisers and parties by booking catering and entertainment services, staffed events, etc.• Implemented use of Microsoft Office and Adobe Acrobat applications to maintain effective management

Deaf Studies

High School

Activities and Societies: Key Club, Varsity Swimming, Varsity Volleyball, Varsity Tennis, Student Government