Documentation Specialist


Admin and Secretarial

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Branch Information

Swiftwater, PA - (USA) 1 Discovery Drive PA Swiftwater , PA 18370



Job Description

The GMP Documentation Technician supports the maintenance of all Good Manufacturing Practice (GMP)/European Union documentation related to the packaging of clinical investigational product: maintenance and distribution control of master batch records, protocol specific product information files, and production batch records, including the transport across campus thereof, and study information file creation; scanning executed batch records and other GMP documentation; completing batch documentation history; archiving Clinical Supply Chain Operations GMP documentation; and participating in projects related to the production scheduling group. This position may assist in supporting the Department during internal and external regulatory audits. Skills Position requires a detailed and quality-oriented person with excellent administrative, organizational, proofreading and verbal and written communication skills. This person must have

the ability to independently prioritize and multi-task with minimal supervision in a team-oriented, production environment. This person should possess a background in records management and organizing and maintaining a secure file/documentation room.

Bachelor's Degree in Business Administration or a minimum of 3 years' cumulative experience working in a GMP/EU regulated environment are required. Experience in a records management capacity handling technical or regulated GMP documents is highly desirable (specifically, technical documents, batch records, and/or standard operating procedures). Computer skills in the following area are required: Microsoft Office Suite and scanning. Document management system or archiving software desirable.