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Jubilant HollisterStier LLC

EM Associate I

Jubilant HollisterStier LLC, Spokane, Washington, United States, 99254

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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

Environmental Monitoring (EM) Associate

is responsible for the monitoring of biological and airborne particulate levels in clean room environments for the purpose of preparation, compounding, and production of sterile injectable drug and 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, digital literacy is highly encouraged for this position. Additionally, EM Associates will need adequate dexterity to don sterile gowns, requiring a level of coordination to balance while ensuring garments control while dressing. Additional responsibilities will include the collection of test samples aseptically, preparation of tools, equipment, and supplies which will be used in a clean room setting, and aseptic observations of aseptic technique.

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

Environmental and Product Sampling

Collect environmental and product samples within ISO 8 cleanroom environments during extended shifts (8, 10, or 12 hours).

Perform gown sampling, area clearance, and product sampling in accordance with departmental procedures and GMP standards.

Monitoring Equipment and Software Use

Operate environmental monitoring and testing equipment, including associated software applications such as MODA, to compile and manage sample data.

Maintain equipment readiness and report any issues or deviations promptly.

Preparation and Sterilization of Supplies

Prepare and organize sampling supplies including totes, labels, documents, tubing, and equipment.

Operate autoclaves to sterilize materials and ensure readiness for sampling activities.

Sample Processing and Incubation

Perform verification and incubation of environmental samples.

Ensure proper documentation and traceability throughout the sample lifecycle.

Documentation and Data Integrity

Accurately enter and verify sample data using MODA and other EM systems.

Maintain high standards of data integrity and completeness in all records and observational memos.

SOP Compliance and Training

Read, understand, and follow applicable SOPs and departmental protocols.

Maintain current SOP training status and complete all required modules within the first six months.

Aseptic Gowning Certification

Obtain and maintain aseptic gowning certification for entry into controlled environments.

Demonstrate proper gowning technique and compliance with badge access protocols.

Support for Requalification and Media Fill Activities

Assist in requalification sampling and media fill qualification processes as directed.

Ensure sampling accuracy and adherence to procedural requirements.

Cleanroom Entry and Alarm Response

Follow badge access protocols for smock and coverall use in designated areas.

Respond appropriately to BAS user alarms and maintain situational awareness in cleanroom environments.

Qualifications

HS Diploma required; AA degree preferred

Previous work experience with strong work ethic required (some overtime would be required)

Minimum 1-year pharmaceutical or laboratory experience desired

Knowledge of cGMPs, 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 desired

Write clear and accurate memos using correct spelling, punctuation and grammar desired

Understand aseptic processing concepts and apply those concepts to job tasks and evaluation of situations desired

MS Word, Excel and Software Aptitude experience 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 required

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.

Shift Weekend Nights, Friday-Sunday E/O Thursday 6pm-6am

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

Hiring Wage:

$25

hr. depending on experience, with opportunity for growth, promotion and annual raises. Midpoint and above is reserved for employees who have longevity with Jubilant HollisterStier and consistently exhibit outstanding performance over a period of time in the role

Shift Differential pay is available for this position, and is determined by hours worked on selected shift.

Weekday Day Shift 12HRS - 2.50%

Weekday Night Shift 12HRS - 10%

Weekend Day Shift 12HRS - 12%

Weekend Night Shift 12HRS - 15%

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

Jubilant HollisterStier is an EEO/AA Employer.

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