Title: cGMP Training Administrator

Job Summary

Training Administrator (cGMP) is responsible for managing the administrative functions of the training system for the Philadelphia locations. Creates, schedules, and conducts cGMP training to maintain compliance with internal and regulatory training requirements including company-wide; department specific; and new employee orientation. This includes managing job codes/matrices, exams, on-the-job training (OJT) documentation to support the site operations and compliance. Serves as Learning Management System (LMS) Training Administrator. Prepares & conducts cGMP Training on as-need basis as per direction of Quality Compliance Management.

Responsibilities

  • Develop and facilitate orientation program for new employees
  • Supporting the conduct of effective new employee orientation sessions in a timely manner
  • Remains abreast of industry standards and FDA enforcement trends so as to facilitate “current” cGMP Training
  • LMS Training Administration, includes development of computer based training materials; Maintaining Training Items, assignments; maintaining companywide curriculums; reporting; data entry
  • Communicate to job code owners, SOP authors and other key stakeholders when tasks are required of them such as exam writing, review and approval, job code evaluation and task initiation. Drive timely completion by stakeholders to support procedure approval timelines
  • Write or revise exams for new and revised procedures in a timely manner
  • Support authors of SOPs in writing and revising exams
  • Manage Job Code organization and structure to ensure employees are trained appropriately, job codes are organized to support the departments and OJT is reflected in the EQMS where possible Generate reports of pending and overdue training including monthly metrics as requested
  • Assist departments who require On-the-Job (OJT) training to manage the structure and documentation of such training as applicable, e.g., lab modules, manufacturing OJT
  • Other assigned administrative tasks as required in keeping the company compliant with cGMP, industry standards and regulations

Knowledge and Skills

  • Bachelor’s Degree in science, pharmaceutical or related field with 2+ years’ experience in cGMP related functions in the pharmaceutical industry or other relevant industry
  • Good written & verbal communication skills for preparing training materials, for conducting instructor-led training sessions, and for written or verbal communication of instructions
  • Experience in using and managing an electronic learning management system Good computer and proficient in the use Microsoft Office applications (Word, Excel, PowerPoint
  • Works well across all departments and functions

Preferred

  • MasterControl or similar Quality Management System (QMS)
  • Certificate or training/learning licenses (CPLP, etc.)
  • Experience with European Union regulations
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