Job Summary:
The Aseptic Training Tech is responsible for training staff on gowning procedures, training staff on proper aseptic technique in ISO 5/7 classified rooms, performing random personnel environmental monitoring, completing aseptic area audits and working in Isotrain software to ensure compliance with quality and regulatory requirements for aseptic processing. Responsible for coordination & scheduling of training activities, delivery of training and skill check evaluations.
Responsibilities:
- Coordinates gowning qualifications, observes staff gowning qualifications and works closely with other department supervision/management to ensure compliance with qualification due dates.
- Performs random personnel environmental monitoring and aseptic area audits inside the ISO 5/7 classified rooms.
- Observes and documents aseptic technique during media fill trials and daily operations.
- Delivers aseptic training for new employee orientation, annual aseptic technique refresher training, routine aseptic technique training and gowning procedure training.
- Participates in and maintains aseptic area audits as required and works closely with manufacturing and quality management to ensure that staff aseptic technique aligns with facility procedures and expectations.
- Performs other duties as determined by management.
Knowledge, skills, and/or abilities :
- Must have knowledge of the gowning process required for ISO 5/7 classified rooms and the ability to gown utilizing aseptic technique.
- Must be able to pass and maintain gowning qualification.
- Must be self-motivated, detail oriented and have strong organizational skills.
- Must have excellent verbal and written communication skills to effectively communicate with all levels of personnel.
- Must be computer literate and willing to work in Isotrain software.
- Must have ability to effectively train others and match training technique with needs of trainee.
- Must be able to flex schedule to provide training on all shifts, as necessary.
Education and/or Experience:
High school dipoloma with minimum 1-3 years pharmaceutical clean room experience.
Physical Demands:
The gowning function of the position requires frequent bending, twisting and reaching.
Work Environment:
Aseptic Training Tech must work in aseptic clean room areas totally gowned with mask, goggles, hood, coverall, boots and gloves.