Operate filling equipment in a controlled or non-controlled area to fill and seal product into containers as specified by batch record, and in accordance with all operational SOPs and cGMP requirements.
The Gown Qualified Operator is responsible for the full spectrum of duties in assigned filing room. This may include but is not limited to: set-up of room and equipment for production, operate equipment to meet product specifications and batch record requirements, ensures correct components and product according to production schedule and batch record, equipment and room cleaning and sanitization, etc This is a 3rd shift position.
One of the following 3 scenarios is required to be considered for the role of a GQO:
3 years of relevant experience + High School Diploma
2 years of relevant experience + Associate’s Degree
0 prior relevant experience + Bachelor’s Degree
Note: Personnel with experience must not have been disqualified from the aseptic areas in the past 12 months.