Job Prerequisites: |
• Strong background in GMP concepts. Experienced in the creation and delivery of GMP concept training. |
• Experienced in the use of e-learning content applications. |
• Must have a working knowledge of current Good Manufacturing Practices, United States Pharmacopeia, current Code of Federal Regulations (21 CFR parts 11, 210, 211, 820), and other FDA regulations and guidances. |
• Meticulous attention to detail, the priority placed on ensuring complete and accurate documentation. |
• Proven success working in a highly cross-functional environment. |
• • Highly self-reliant and capable of quickly solving problems and resolving conflicts at various levels. Ability to think critically and make decisions based on instructions and previous experience. |
• Outstanding interpersonal and communication skills combined with a sincere passion for enabling others through training. |
• Computer savvy and comfortable operating within a variety of different systems is a must, prior experience working within complex databases is a plus. Knowledge of e-learning principles. |
• Exceptional organizational skills and detail oriented. |
• Strong customer service skills to support internal and external customers. |
• Strong interpersonal skills with the ability to interact and relate effectively, productively, and positively with other Associates. |
• Employees are required to work a 40-hour week. In special circumstances, additional hours during the weekdays, evenings, and/or weekends will be required to complete tasks and meet deadlines. All applicants must be able to meet the attendance standards. |
• Able to use personal computer and standard office equipment such as fax and copy machines, calculators, and printers. Aptitude to learn computer programs as needed (i.e. Microsoft Office Word, Excel) in addition to other business applications. |
• Strong verbal and written communication skills. Resourceful and well organized. |
• Ability to read and interpret standard documents such as: procedure manuals, employee handbook, and job-related publications. Ability to write routine reports and correspondence. |
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. |
• The individual must be proficient in the Microsoft Office Software Suite (incl Word, Excel, and PowerPoint). |
• Experience with UL Compliance Wire Highly recommended. |