Softworld GMP Training Specialist - Senior -2144- 95 in Lexington, Massachusetts

GMP Training Specialist - Senior -2144- 95

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Date posted:

October 03, 2016

Job Type:



Lexington, MA

Job ID:



Senior Training Specialist • Senior Training Specialist to join the training department in Lexington. • Will support training activities for Quality and Manufacturing groups. • The primary responsibility of the Training Specialist position will participate in developing and implementing a comprehensive on the job training program and lead the design and delivery of training programs related to compliance and job function knowledge and skills. Additionally, this individual will participate in establishing training best practices and processes related to a comprehensive on the job training program. • Lead the development and delivery of training content, evaluations, instructional and hands on exercises, including e-learning to support competency based training. This includes collaborating with other functions to identify and make decisions related to training development and implementation, review of training content for effectiveness and providing guidance and /mentoring to subject matter experts and other members of the training team. • Participate in project team(s) to improve the competency based training program. This includes assisting with the implementation of standard methodology and templates for developing, implementing and maintaining training content for on the job training and participating in establishing training policies, processes and standards across sites. • Assist with other department activities as needed including the delivery of training (e.g. GMP training, Quality Systems, Train the Trainer) and generating training reports. Required Skills: • Requires a degree in relevant discipline or equivalent experience. • 10+ years of experience developing, delivering and assessing training in both one-on-one and classroom settings. • 10+ years of experience developing and deploying competency-based instructor lead and e-Learning training programs. • Understanding of GMP requirements. • Complete understanding and application of instructional design and adult learning principles, concepts. • Experience with building a competency based training process/program. • Experience with training software such as Articulate is a preferred. • Ability to prioritize, plan, schedule and arrange own activities in accomplishing objectives under minimal supervision. • Complete understanding and successful application of principles, concepts, practices, and standards related to solid instructional design principles in developing instructor lead (classroom and on the job) and e-Learning training programs. • Technical Writing skills. • Effective communication skills both verbal and written. • Working knowledge of cGMP requirements. • Strong collaborative, interpersonal, professional and customer focused skills with people at all levels in the organization. • Ability to problem solve. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. • Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with all levels internal and external personnel in area of expertise. • Develop solutions to a variety of complex problems. • Refers to established precedents, best practices and policies. Work is performed under general direction. • Participates in determining objectives of assignment. • Plan schedules and arranges own activities in accomplishing objectives. Work is reviewed upon completion for adequacy in meeting objectives. • Position will report into the GMP Compliance function. Position will require interactions cross-functionally. • Periodic travel required for business meetings with peers/collaborators and training within the Lexington/Cambridge area. Duration: Contract slated until the end of April