Environmental Monitoring (EM) Associate - Weekend Days

About the role

Jubilant HollisterStier LLC, Spokane's Largest Manufacturing Company, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. 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.

Training requirements (first six months)

• 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 (some overtime 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
• Experience in MS Word and Excel 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

Schedule

Weekend Days: Friday-Sunday, Thursday 4:30AM-4:30PM

Compensation & benefits

• 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