Address
Form of workThe Training resource is required to support and enhance the quality training programs related to key
compliance initiatives, applicable regulatory requirements, as well as local and global processes.
Primary duties include administration of the
Cornerstone Learning Management System, including but not limited to, curricula maintenance, data entry and assessment creation.
In addition, the position evaluates existing training programs and data trends to identify training needs and develop new training. This evaluation assesses the adequacy of training materials and programs in a GxP environment. Position will work closely with , business units and management to streamline/
progress training needs.
Primary Responsibilities
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Identifying, recommending, and implementing improvements to the training function to make it
more effective and efficient in supporting business objectives and compliance requirements
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Facilitating the development of training curricula for US Sites
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Perform training needs analysis and effectiveness assessments and deliver programs as deemed
appropriate. Coordinates/delivers other regulatory training as required.
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Ensuring training documentation is accurate and compliant with Good Documentation Practices
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Coordination with GxP Training colleagues to develop and implement training programs to improve training effectiveness, current practices and optimize operations.
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Maintains GXP training files, ensures GXP files are current and in compliance with regulations
and internal procedures
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Coordinates with LMS owner to provide training records as requested in support of external and
internal audits
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Provide Training SME input on deviations, Laboratory Investigations, Planned Deviations, Change Controls and CAPAs
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Education and Experience
Temp Resource, GxP Training must have:
BS required for external candidates and 4 years minimum relevant experience, or equivalent
level of experience in pharmaceutical or related industries; or graduate degree (MS preferred)
with 2 years minimum relevant experience
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Necessary Knowledge, Skills, and Abilities
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A thorough understanding of cGMP and excellent working knowledge of FDA regulations
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Preferred experience in managing LMS systems (Cornerstone would be ideal)
Howard Systems International, Inc.
1
http://www.howardsystems.com
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Experience in establishing training effectiveness programs
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Possess a strong ability to resolve and communicate technical issues and perform root cause
analysis
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Demonstrated ability to act as a functional expert
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Ability to negotiate needed actions and manage difficult interactions effectively.
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Knowledge of computerized support tools and training software
Should have Learning Management System (LMS) experience and preferably with Cornerstone
LMS.
Must have Pharmaceutical domain experience in recent employment.
Should have expertise in cGMP, Gxp and FDA Regulations.
