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QA Specialist - Documentation and Training

Company: Bristol-Myers Squibb
Location: New Brunswick
Posted on: August 14, 2019

Job Description:

Save Education - Bachelor's Degree Skills - Computer Literacy - CGMP - Enterprise Software - Microsoft Office Benefits - Health Insurance Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results. Summary: - Ensure compliance within the organization as it pertains to documentation and records management. - Provide support as a Content Manager of various PD Electronic Document Management Systems (e.g. DocMan, PDHQ) and BMS Records Management Systems - Audit readiness and support - Metrics generation and communication (i.e. upcoming periodic reviews, schedule for off-site storage and/or destruction) - Support compliance within the organization as it pertains to training and audit support. - Provide support as a Content Manager of various PD Electronic Document Management Systems (e.g. ELMS, PDHQ) and BMS Records Management Systems - Audit readiness and support - Metrics generation and communication - Provide support on the implementation and maintenance of the training program and Quality Management systems such as but not limited to Infinity and QUMAS Responsibilities: Utilize the Records Management System to manage hardcopy GMP documents submitted for retention and archival. Provide support for procedural documentation, records management, and audit support processes. Provide support for paper Master Batch Record preparation, forms and logbooks/notebooks issuance, tracking and reconciliation for the NBR site. Provide third party oversight for notebook/logbook design, print and issuance to BMS. Provide overall PD functional area oversight for document control/records management. Provide regulatory/inspection and internal audit support. Participate in the GPS Learning Community of Practice. Drive change and support alignment and harmonization of 'best training practices' across the GPS network. Build and foster strong relationships and partnerships with stakeholders and support groups to meet the demands of a changing business culture and environment. Provide administrative support of the Electronic Learning Management System (ELMS) and the records management system. Support training program by conducting supplementary Community of Practice meetings for ELMS administrators, providing oversight on RBCs and training programs within PD for consistency Support the development of training project plans and perform all the necessary activities to support successful implementation. Assist with the creation of quizzes for training items utilizing Pedagogue or equivalent software. Provide appropriate internal audit/regulatory inspection support relevant to training documentation. Build and foster strong relationships and partnerships with stakeholders and support groups to meet the demands of a changing business culture and environment. Adherence to BMS core behaviors Professional experience and qualifications: B.S. with 2+ years of relevant experience, preferable in a regulated industry Experience within a QA environment is required Knowledge of ELMS and other Enterprise Systems (i.e. DocMan, PDHQ, SuccessFactors) is highly desirable. Familiarity of GMP regulations Strong collaborative skills Effective written and verbal communication Computer literacy: Microsoft Office and other systems as required Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Keywords: Bristol-Myers Squibb, New Brunswick , QA Specialist - Documentation and Training, Other , New Brunswick, New Jersey

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