The aseptic cleaning technician is expected to possess a clear understanding of the GMP operation. This position involves cleaning and sanitization of processing equipment, parts, and rooms. The technician maintains documentation of forms and logbooks as required by corporation and regulatory agencies. The candidate will prepare cleaning solutions according to procedures, stocks gowning supplies and removes waste from the core area.
- Perform sanitization duties in the cleanrooms while aseptically gowned
- Accurately record and complete documentation as required, including logbooks and forms in compliance with SOP guidelines
- Remove and collect all used disinfectant solution waste and place in the appropriate disposal unit
- Prepare cleaning solutions and sanitize sterile/nonsterile production areas
- Maintain facility and equipment through routine cleaning and sanitization in designated areas within the cleanroom as indicated in standard operating procedures
- Adhere to Standard Operating Procedures (SOP), Good Documentation Practices (GDP), and current Good Manufacturing Practices (cGMP)
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management rights to assign and reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
Reports to: Fill & Finish Manager, Manufacturing
Minimum Education, Experience and Skills:
- Minimum of High School Diploma or equivalent and 1 year of experience with biologic production processes under GMP compliance
- Excellent documentation skills including comprehension review & establishing batch production records