Quality Assurance Trainer
• Provide training to new employees on cGMP concepts, SOPs, Batch Record execution, Batch record reviews, and Investigations
• Basic understanding and knowledge of techniques, instrumentation, and lab functions to identify problems and support the completion of work assignments.
• Work with Manufacturing trainer to develop and implement a training program for chemist.
• Review proposed SOP revisions and provide feedback to management
• Real-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parameters
• Perform room and equipment clearances per procedure following cleaning conducted by production.
• Data entry to support water, HVAC, and other utilities
• Complete additional tasks as assigned by the supervisor
• Other responsibilities as assigned
• A Bachelor’s Degree is preferred.
• Biology, Chemistry, or other Life Science degree is preferred.
• At least 1 year of work experience in a GMP (Good Manufacturing Practice) facility is preferred.
• Computer skills in MS Word, EXCEL, and Outlook
• Strong interpersonal and communication skills (oral and written).
• Must be able to push, pull, squat, stand and walk through-out the day
• Must be able to lift up to 20lbs
• Must be able to wear safety shoes & glasses through-out the day while in designated areas. (provided by the company)
• You must be cleared by a physician to wear a respirator throughout the day while in designated areas.
• Must be ok working in a chemical environment.