Senior Training Specialist- Somerset NJ 08873 Req: (9214426) Must have: compliance wire, pharmaceutical and training experience
This position is responsible for the development, management and organization of the training function to assure that employees and managers are properly trained to perform their assigned duties, and that training systems are maintained to meet cGMP requirements. Work closely with management to identify training needs and requirements and implement technical and management development training programs to support business unit objectives. Design and develop training materials; manage trainer certification and training effectiveness evaluation systems. Ensure that the required technical, developmental and regulatory training is implemented in order to achieve compliance, business objectives and development of employees. Review SOP s, cGMP, product related technical information, protocols, etc. to ensure technical training materials developed are current and in compliance with regulatory agencies and Company procedures. Establish and manage training documentation system(s) to ensure employees including temporary and contracted personnel training records are current and in compliance. Keep abreast of training and equipment options and technology changes; provides proper consulting information to ensure training effectiveness. Develop and implement training initiatives, assess progress, and focus on the continuous improvement on training materials, programs and processes. Work with and evaluate the quality and effectiveness of employees who provide training. Apply adult learning concepts to lead and participate in on-going training mechanisms (e.g. print, web, CD, audio, video, and distance). Effectively communicate to all departments the requirements for training and provide follow-up. Provide direct support for customer/regulatory audits and responses to those audits. Oversee New Employee Orientation. Manage all activities of the Training Department including the tracking of training projects and initiatives. Develop new procedures and revise existing procedures as required. Perform training of personnel as required. Represent the Training Department on project teams, management meetings and internal/external forums. Develop and provide training metrics information as required. Report project status and site trends to Senior Management. Education : Candidate should have a BS/BA in Chemistry, Microbiology, Biology, or related discipline, or the equivalent knowledge with two to five years of experience in the pharmaceutical industry.
Experience : At least five years pharmaceutical quality experience.
Knowledge/Skills: Strong analytical technical skills and oral/communication skills a must. Ability to develop training programs and strategies. Auditing experience is desirable. Must demonstrate organizational skills, be able to interact with personnel at all levels from a variety of disciplines and be knowledgeable in cGMPs. Superior customer service orientation with strong follow-up skills and attention to detail. Willingness to travel. Advanced PC skills, knowledge of company specific software packages. Must be a self-starter, be able to work independently and have the ability to multi-task under strict deadlines. Must have experience with ComplianceWire. Individual s primary workstation is located in the office area, where the noise level is low. Employee will be present on the manufacturing floor where the noise level is low to moderate.
Hours : 8:00am to 5:00pm
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* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.