Quality Control Core 1

Job Description

Job Description

Position Description :

Description :

Title : Environmental Monitoring Technician

Temp to perm potential

10am / 12pm start time - 8 hours a day

Monday-Friday

Shift differential : 7%

3 positions on first shift

Aseptic Technique / comfortable in clean rooms

entry level microbiologist

water collection

GDP

willingness to learn

Background Qualifications :

High School diploma required as minimum. Associates degree and / or related certification in Microbiological Sciences highly preferred.

Experience with aseptic technique and / or working in aseptic environments.

Ability to gown aseptically for Manufacturing and Aseptic Filling areas.

As persons in this role are engaged in sampling and environmental monitoring during open manufacture of medicinal products, individuals must not be affected by an infectious disease nor have open lesions on any exposed surface of the body.

Working hours will require flexibility with available work hours.

Sufficient mobility to work in manufacturing processing areas is required.

Major Position Activities & Responsibilities :

Environmental monitoring of the aseptic area during production fills or weekly monitoring

Must immediately notify supervisor if affected by infectious disease or open lesions on body, as individuals are not permitted to enter manufacturing areas or handle product if these conditions exist.

Water collection and testing of WFI, Clean Steam, and the Deionized Water

Performs media fill qualification and release in support of environmental monitoring program.

Perform sampling activities in support of environmental investigations

Maintenance of the cleanliness of the microbiology laboratory area, refrigerators, and incubators

Handling of wastes including hazardous wastes. Attendance at mandatory annual hazardous waste training meeting(s). Demonstration of competency in training by passing test(s) administered by the company or consultant providing such training.

Responsible for adhering to the Environmental, Health and Safety program.

Performs special projects and other duties as assigned.

As a part of the employees job requirements, the employee may be required to handle wastes including hazardous wastes. The employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing test(s) administered by the company or consultant providing such training.