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QA Specialist - Documentation and Training

Company: Bristol-Myers Squibb Company
Location: New Brunswick
Posted on: October 22, 2019

Job Description:

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 QUMASResponsibilities:

  • 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 behaviorsProfessional 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 requiredBristol-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 Company, New York , QA Specialist - Documentation and Training, Other , New Brunswick, New York

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