Quality Specialist III, GxP Training

Company: Katalyst Healthcares & Life Sciences
Location: Wilson
Posted on: May 26, 2023

Job Description:

Job Description

Responsibilities:

• 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. Requirements:
  • BS required 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
  • 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
  • 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
  • bility to negotiate needed actions and manage difficult interactions effectively.
  • Knowledge of computerized support tools and training software
  • 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.
  • bility to work a 10 hour per day/4-day work week; 40 hours per week with overtime as required.

Keywords: Katalyst Healthcares & Life Sciences, Wilson , Quality Specialist III, GxP Training, Other , Wilson, North Carolina