Sr. Gxp Trainer - (US-NJ-Branchburg - 08876)

Minimum Education: None
Job Type: Full Time
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Responsibilities : Develop and deliver GXP and Quality System Training for internal personnel. 2. Develop/deliver training programs to address CAPAs, as needed. 3. Ensure Trainer Qualification is achieved and maintained for internal GXP Trainers. 4. Review and disseminate pertinent GXP related literature and relevant FDA activities to OLAD and the GXP cross functional groups, as applicable. 5. Develop/deliver New Hire Orientation, GXP, and Quality System Training Programs. 6. Develop e-Learning Courses for GXP and Quality Systems and develop other E-Learning initiatives, as required. 7. Provide consultation to internal client groups regarding training issues associated with non-conformance events and audits. 8. Work closely with internal client groups to provide relevant and group specific technical training opportunities via Webinars, Teleconferences, and seminars. 9. Ensure Training Effectiveness by developing appropriate Training Assessments. 10. Develop and implement new OLAD training initiatives, as required. 11. Manage/supervise projects and/or project teams, as requested. 12. Serve as a resource for establishing core GXP training requirements.

Requirements :BA/BS degree in the sciences or relevant Technical discipline 2. 3-5 years (7-10 years, Senior) experience in the Pharmaceutical/Biotech industry including experience providing training on GXPs and Quality Systems. 3. Must possess a thorough knowledge of GXP regulations and other regulations as applicable. 4. Must have experience managing projects, managing project teams and/or supervising staff. 5. Must be capable of working independently with minimum direct supervision. 6. Biotech/Pharmaceutical manufacturing, laboratory, and/or QA experience is required. 7. Strong understanding of all Quality functions and business areas is required. 8. Excellent written and oral communication skills are required. Must be computer literate.

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