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Job Summary |
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Sr. GXP Trainer
Job Code: 856552
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POSTED: Oct 29
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| Salary: |
Open |
Location: |
Branchburg, New Jersey |
| Employer: |
ImClone Systems |
Type: |
Full Time - Experienced |
| Categories: |
Education / Training, Operations |
Required Education: |
4 Year Degree
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Job Description |
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The GXP Trainer is responsible for developing and delivering a comprehensive, interactive, and compliant GXP Training Program for those ImClone Systems employees working in a regulated environment. He/she is responsible for ensuring compliance with the umbrella training policy and procedure and group specific training procedures for ImClone Employees. He/she will execute and/or coordinate GXP and Quality Training Programs for GXP regulated cross functional groups. The GXP Trainer will evaluate internal compliance profiles, identify training needs, and develop targeted training programs with support from Management. He/she will provide support for training-related issues to GXP regulated cross functional groups, be a GXP Subject Matter Expert, and will ensure that current GXP related literature articles and relevant FDA activities are disseminated to OLAD and the GXP cross functional groups, as applicable. This position will develop and implement new OLAD training initiatives and manage projects, as requested, and will also be a resource for establishing core GXP training requirements for GXP cross functional groups. He/she will develop GXP and Quality e-Learning course content, as required, and will develop, deliver, and/or facilitate Technical Training Programs, as necessary.
ESSENTIAL DUTIES AND RESPONSIBILITIES
1. 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 GXP 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. 13. Attend GXP/Quality System Training Programs as required.
| NOTES: |
Local Residents Preferred (No Relo)
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Requirements |
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ESSENTIAL KNOWLEDGE, SKILLS, EXPERIENCE
1. BA/BS degree in the sciences or relevant Technical discipline 2. Minimum 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. 9. Must have strong computer skills, including MS Word, PowerPoint and Excel. Experience with Project Management and e-Learning is desirable.
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