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: 

• 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 diploma 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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