Job Description

SUMMARY:

A quality assurance trainer delivers appropriate quality assurance training to company personnel. They are chiefly responsible for designing and delivering effective QA training programs within the company.  Additionally, the job also involves working proactively within the company and interacting with a wide range of employees to conduct training programs and to support product launches and program enhancements.

RESPONSIBILITIES:

• Maintain, manage comprehensive filing system and computer database for all documents to be retained in the document center as they pertain to training
• Manage training plans for all functions and collaborate with site management to develop training plans for new positions
• Maintains quality training requirements in compliance with FDA and other regulations. 
• Develop GMP Training and deliver GMP training to new hires and annual GMP training for regular employees
• Design and/or assists with design of training programs of new and existing employees, including implementation and evaluation 
• Develop procedures and policies including creation, update and maintenance of relevant documentation
• Prepare a yearly training plan with input from all relevant departments and levels of management. Ensure adherence to the training plan
• Inspection readiness for all training requirements
• Monitor, track, and report training metrics
• Review site metrics to determine and meet site training needs
• Evaluate training effectiveness and adjust to resulting trends

KNOWLEDGE AND SKILL:

• Excellent knowledge of MS Office. MS Word skills required: Templates, styles, headers, working with cross referencing figures, tables, and sections
• Working knowledge of FDA, QSR, GMP, and ISO13485 is a plus

EDUCATION/EXPERIENCE REQUIRED:

• Bachelor’s Degree or equivalent experience plus a minimum of 2 years detailed oriented work experience in an FDA regulated and/or cGMP environment required
• Two years’ experience as a trainer in a regulated environment