Description: Independently performs the tasks of the production operation specific to aseptic cleaning. Maintains batch record documentation and logs as required by corporation and regulatory agencies. Must be able to perform cleaning and sanitizing of production equipment and classified production space. Perform routine daily and weekly cleaning of Aseptic and Classified manufacturing rooms grade A-D.
Serve as witness to routine unit operational tasks for batch record signing. Maintains all associated documentation for operations being performed.
Demonstrated ability in the application of requisite skills and applies additional skills and acquired knowledge while following established practices and procedures. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The majority of the work activities are performed while standing. " Move transfer carts in and out of manufacturing area " Ability to stand over intervals of several hours at a time " Ability to bend, squat, and reach " Ability to lift, push, or pull various amounts of weight Based on production schedules, random and different start time scenarios may occur so a very flexible work schedule is required for the candidate. Ability to accommodate production requirements that may require 50+ hour workweeks extended day hours and weekends. This role requires frequent work on weekends depending on production demands.
Educational Requirements: High School Diploma or GED. Pharmaceutical and clean room experience for the aseptic production of sterile products, is preferred; cGMP experience preferred.