Job Summary

• Provide business administration support for the CSOD system for the Wilson site, including assessment of quarterly system releases vs. business needs.

• Support validation testing of system changes, upgrades from an SME perspective.

• Meet with business functions routinely to identify, recommend, and implement improvements to the training function to make it more effective and efficient in supporting business objectives and compliance requirements. This should reflect industry best practices.

• Facilitate the development/maintenance of training curricula for the RTP and Wilson sites.

• Perform training needs analysis and effectiveness assessments as deemed appropriate.

• Coordinates/delivers other regulatory training as required.

• Ensure training documentation is accurate and compliant with Good Documentation Practices

• Coordinate with Training colleagues at the Stamford site to develop and implement training programs to improve training effectiveness, standardize practices and optimize operations

• Establish and maintain industry contacts on current compliance and training issues by participation in external Training industry groups.

• Proactively support company priority initiatives with activities that are outside planned responsibilities and objectives.

• Maintain electronic and paper GXP training files, ensures files are current and in compliance with regulations and internal procedures.

• Coordinate with LMS owner to provide training records as requested in support of external and internal audits.

• Provide SME input on deviations, Laboratory Investigations, Planned Deviations, Change Controls and CAPA.

• Provide training direction, analysis, and guidance regarding quality related compliance. Perform other related assignments and duties as required and assigned.

  Education and Experience

• BS required and 4 years minimum relevant experience, or equivalent level of experience in graduate degree (MS preferred) with 2 years minimum relevant experience

  Necessary Knowledge, Skills, and Abilities

• A thorough understanding of cGMP and excellent working knowledge of FDA regulations

• Experience in managing curricula in Cornerstone on Demand or similar LMS

• Preferred experience in the creation of Manufacturing/Laboratory On-boarding programs

• Experience in establishing training effectiveness programs

• A strong ability to resolve and communicate technical issues, and perform root cause analysis

• Demonstrated ability to act as a functional expert and provide input as such

• Ability to negotiate needed actions and manage difficult interactions effectively.

  Knowledge of computerized support tools and training software Physical and Environmental Requirement

• Perform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching. While sitting for an extended period of time on a routine basis, incumbent may use the following equipment: Personal computer, telephone/ other voice communication devices, copier, fax, scanners, or other specialized equipment used in an office setting.

• Ability to work a 10 hour per day/4-day work week; 40 hours per week with overtime as required.