Associate, Environmental Monitoring

Jubilant HollisterStier LLC, Spokane’s Largest Manufacturing Company, and well-established member of the business community, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. Jubilant HollisterStier is a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. 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 EM Associate 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; thus, computer understanding is highly encouraged for this position. Additionally, EM Associates will need dexterity to don sterile gowns, requiring a level of coordination to balance while ensuring garments do not touch floors while dressing. Additional responsibilities will include the collection of test samples aseptically, and preparation of tools, equipment, and supplies which will be used in a clean room setting.

Within the first Six (6) Months training requirements will include but are not limited to:

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 require using Master Control

Qualifications:

• HS Diploma required; AA degree preferred
• Previous work experience with strong work ethic (some overtime would be required)
• Minimum 1-year pharmaceutical or laboratory experience desired
• Knowledge of cGMP’s, operation of autoclaves, aseptic technique, and basic computer skills desired
• Must be able to read and understand directions dictated in procedures with little to no assistance
• Write clear and accurate memos using correct spelling, punctuation and grammar
• Understand aseptic processing concepts and apply those concepts to job tasks and evaluation of situations desired.
• MS Word, Excel experience required
• Software Aptitude knowledge required
• Ability to work with computer and tablets required
• Mechanical Aptitude and Manual Dexterity required
• Ability to lift 25 lbs unassisted, pushing, pulling, prolonged standing and sitting, twisting required
• Must have dexterity, and physical balance to perform aseptic gowning requirements.
• Must maintain high degree of personal hygiene to work in aseptic environments required
• To work in aseptic environments employees may not have open wounds, fake (nails, eyelashes, hair), perfume/cologne, cosmetics.
• Exposure to allergens, working in aseptic areas, working in confined spaces required

Shift: Weekday Nights, Monday-Wednesday E/O Thursday 6p-6a

Compensation & Benefits:

This is an on-site, full-time position located in Spokane, WA.

• Hiring Wage: $25/hr.
• Medical, Dental, Vision, Flexible Spending and Health Savings Accounts
• Life, AD&D, Short and Long Term Disability
• 401(k) with company match
• Generous paid time off plan
• Employee Assistance Program

Unlock your potential with Jubilant HollisterStier! If you’re seeking a dynamic and rewarding career, we welcome your Application today!

https://jubilantcareer.jubl.com/

*Please click on the Spokane, Wa. Link*

Jubilant HollisterStier is an EEO/AA Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If you require assistance applying for a position, please contact our HR Department at:

JHS-TalentAcquisition@jubl.com