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

* Coordinates annual gowning qualification program, 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.

* Delivers aseptic training for new employee orientation, annual aseptic technique refresher training, routine aseptic technique training and gowning procedure training.

* Maintains tracking for aseptic area access.

* 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.

* Writes trending reports.

* Performs other duties as determined by management.

QUALIFICATIONS

* 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.

* 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.

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

Location:

Cherry Hill, NJ, US, 08003

Nearest Major Market: Philadelphia