DOCUMENTATION & TRAINING ASSOCIATE(Job Number: 1204452)
The Documentation & Training Associate will provide Biologics Development Quality Operations (BDQO) and Biologics Manufacturing and Process Development (BMPD) group members with documentation and training support. This individual will serve as an administrator of the Electronic Learning Management System (ELMS), build quizzes, create & maintain curricula, and assign training to ensure timely completion of quality group and functional area training. The Documentation & Training Associate will coordinate training events, assist with training initiatives, and perform routine documentation and training administration functions. This position will provide support for the records management system (RMS) and the electronic document management system (EDMS). This person in this role will be responsible for maintaining hybrid training files and other GMP documentation such as calibration reports, log sheets, and validation reports. Additionally, this individual will coordinate completion of the quarterly security access review for controlled areas. The Documentation & Training Associate will also create, administer, and perform periodic review of accounts for TrackWise® and other systems used by GMP or support personnel at the site. Other duties and responsibilities may include audit preparation, site inspection readiness, and participation in regulatory and internal audits at the site.
Bachelor’s degree (or equivalent) is required. A minimum of 2 years relevant experience focused on training and documentation is desired. Knowledge of cGMP regulations is preferred. Strong knowledge of and experience with Microsoft Word & Excel and ELMS/EDMS software –such as Plateau & Syncade – is desired. Requires excellent communication skills and the ability to work in a team based environment and interact well with other employees at various levels. Personnel must demonstrate strong organizational skills, flexibility and have the capability to handle several high priority items simultaneously on an ongoing basis.
Job Function: Quality
Primary Location: NA-US-NJ-Hopewell
: Tech Op - CNJ - Worldwide Quality & Compliance
Bristol-Myers Squibb - 21 months ago
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