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Jubilant HollisterStier LLC, a well-established member of the business community in Spokane, Washington, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is also a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. Jubilant HollisterStier is a proud member of the Jubilant Pharma family.

Our Promise: Caring, Sharing, Growing

We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions' through growth, cost effectiveness and wise investment of resources.

Job Description:

The Environment Monitoring Associate (EM) is responsible for the monitoring of biological and airborne particulate levels in clean room environments for the purpose of preparation, compounding, and filling of sterile injectable drug products.

The EM Associate will be trained on proper aseptic behavior, sanitization processes, and donning of sterile gowns. Associates will be required to have an aptitude for reading detailed procedures, clear documentation practices, and operating several environmental software applications. Essential responsibilities include but are not limited to:

Within the first Six (6) Months you will:

1. Collect product and environmental samples within an ISO 8 environment over extended periods of time (Typical EM shifts include 8, 10 and 12 hour days).
2. Operate appropriate monitoring sampling and testing equipment including associated software applications to compile data.
3. Prepare supplies required for collecting and testing of samples.
4. Operate Autoclave to prepare/sterilize supplies as needed.
5. Perform verification and incubation for EM samples.
6. Verify data for accuracy.
7. Read and understand SOP's as required. Maintain current SOP training requirements.
8. Obtain Aseptic Gown Certification

Six months (6) to Twelve (12) months:

1. Successful gown certification for ISO 7, 6, and 5 classifications, environmental monitoring and collecting test samples related to defined quality parameters for surface, air, personnel, product and utility systems such as compressed gas and WFI.
2. EM Associate must complete EM training in at least one of the major aseptic areas ISO 5.
3. Redline and review SOP's as required.
4. Write clear concise observational memos and assist in investigation of controlled areas.
5. Review environmental data; verify all monitoring data are received from controlled areas prior to incubation of monitoring plates into appropriate incubators.
6. Perform training for Aseptic Area Gown Certification and SOPs.
7. Obtain train the trainer certification.

Twelve (12) months to Twenty-four (24) months:

1. Cross train on multiple sterile filling lines, maintain successful gown certification for ISO 7, 6, and 5 classifications, maintain a high level of right first time adherence to GMP procedures and documentation practices.
2. Assist in environmental investigations.
3. Read testing results, review and trend environmental data.
4. Perform leadership function for specified area of assignment, to include training program management for assigned technicians.
5. Assist the Specialist/Supervisor in evaluation of resources needed to complete assigned tasks.
6. Review/Change EM SOPS as required using Master Control.

Qualifications:

HS Diploma required. Associate degree preferred.

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