Title:  Aseptic Technician

Job Summary:

The Aseptic Technician 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: 

1. Coordinates gowning qualifications, observes staff gowning qualifications and works closely with other department supervision/management to ensure compliance with qualification due dates.
2. Performs random personnel environmental monitoring and aseptic area audits inside the ISO 5/7 classified rooms.
3. Observes and documents aseptic technique during media fill trials and daily operations.
4. Delivers aseptic training for new employee orientation, annual aseptic technique refresher training, routine aseptic technique training and gowning procedure training.
5. 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.
6. Performs other duties as determined by management.

Knowledge, skills, and/or abilities : 

1. Must have knowledge of the gowning process required for ISO 5/7 classified rooms and the ability to gown utilizing aseptic technique.
2. Must be able to pass and maintain gowning qualification.
3. Must be self-motivated, detail oriented and have strong organizational skills.
4. Must have excellent verbal and written communication skills to effectively communicate with all levels of personnel.
5. Must be computer literate and willing to work in Isotrain software.
6. Must have ability to effectively train others and match training technique with needs of trainee.
7. 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 Tech must work in aseptic clean room areas totally gowned with mask, goggles, hood, coverall, boots and gloves.

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