Title: Training Specialist
Contract: 8 Months
Location: Hopewell, NJ - 08534
Job Description:
General Description:
- Understand GxP training and LMS software to troubleshoot problems and provide compliant and practical solutions to meet user needs.
- Build and maintain items in the LMS such as training items, curricula, user groups, quizzes, smart forms and assignments.
- Build reports, queries and data extracts as requested.
- Cross-functional collaboration to ensure the GMP compliance of day-to-day operations.
- Manage new employees' related GMP training.
- Provide support for personnel training records and archiving.
- Ensure site training compliance expectations are communicated.
- Create training job aids with critical information for training and on-boarding.
- Provide KPIs to management for tracking of essential training requirements.
- Assist in the site training and documentation operations with the close collaboration with global teams.
- Maintain accurate records and documentation, a necessary.
- Ensure compliance with regulatory requirements, industry standards, and company policies in all training activities.
- Undertake any other duties, either for this department or any other department within the business, which may be requested by the Line Manager, for which training and/or an explanation has been provided and understood.
Skills:
- Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint), Visio, Smartsheet, Veeva, LMS training software.
- Experience managing enterprise applications and/or systems management.
- Experience with ComplianceWire or similar LMS
- Experience with Document Management Systems (preferably Veeva QualityDocs) and Human Resource Information Systems (preferably Workday)
- Customer focused
- Ability to collaborate with global teams and learners from diverse backgrounds
- Excellent leadership and communication skills
- Excellent analytical and troubleshooting skills
- Understanding of GAMP and or 21 CFR Part 11
Required
- PHARMACEUTICAL MANUFACTURING
- CGMP
- DETAIL ORIENTED
- DOCUMENT MANAGEMENT SYSTEMS
- LEARNING MANAGEMENT SOFTWARE
Education:
- Minimum Associates Degree