Aseptic Training Associate - 2nd Shift

SUMMARY

The Aseptic Training Associate 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 compiling trending reports 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 annual gowning qualification program, 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.
4. Delivers aseptic training for new employee orientation, annual aseptic technique refresher training, routine aseptic technique training and gowning procedure training.
5. Maintains tracking for aseptic area access.
6. 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.
7. Writes trending reports.
8. Performs other duties as determined by management.

 

QUALIFICATIONS

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.
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.

 

EDCUATION AND EXPERIENCE

BS/BA Degree in Microbiology or Biology with 1-3 years pharmaceutical microbiology experience. Microbiology coursework and laboratory work utilizing aseptic technique is required.

Physical Demands:

The gowning function of the position requires frequent bending, twisting and reaching. 

Work Environment:

Aseptic Training Associate must work in aseptic clean room areas totally gowned with mask, goggles, hood, coverall, boots and gloves.

 

What We Offer

• Clean climate-controlled working environment
• Annual performance bonus potential
• 401k employer match up to 6% of your contributions
• 23 vacation/personal days
• 11 paid Company holidays
• Generous healthcare benefits
• Employee discount program
• Wellbeing rewards programs
• Safety and Quality is a top organizational priority
• Career advancement/growth opportunities
• Tuition Reimbursement
• Maternity and Parental Leave

 

*Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms