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 :

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.

Location :