Aseptic Process & Training Senior Associate — SME & Trainer

Jubilant Pharma, LLC; Spokane (WA); On-site; USD 67,000 - 78,000; Full time

Benefits offered by this job

Medical, Dental & Vision coverage

Flexible Spending Accounts (FSA) & HSA

Life & AD&D Insurance

Disability Insurance

Employee Assistance Program

Job summary

Jubilant HollisterStier LLC in Spokane, WA is seeking a Senior Associate for Aseptic Process & Training to maintain and advance the aseptic training program. You will serve as SME on aseptic technique across Jubilant Manufacturing Facilities and lead training initiatives to ensure best practices in a regulated environment.

The role requires a BS in Biology (Microbiology) with 5+ years in aseptic processing, and hands-on experience with TrackWise, LMS, and MasterControl.

Qualifications

• Bachelor of Science in Biology with emphasis in Microbiology.
• Minimum 5 years of experience in aseptic processing.
• Pharmaceutical experience.
• FDA-regulated industry experience.
• Understanding of aseptic processing.
• Clean room behavior.
• Proficiency with Word, Excel, PowerPoint, TrackWise, LMS, and MasterControl.
• Analysis/diagnosis or production task impact on end results.
• Adherence to defined policies with managed reviews.

Responsibilities

• Maintain aseptic training program and SME input on aseptic practices.
• Perform SOP review, auditing, training, and investigational duties.
• Maintain current knowledge of regulatory expectations for aseptic processing sites.
• Coordinate with Regulatory and Compliance projects as needed.
• Maintain and deliver aseptic training content for new hires and ongoing roles.
• Own aseptic processing SOP and align with best practices.
• Conduct aseptic behavior audits across areas.
• Review audit outputs and mitigate gaps.
• Maintain gown certification and participate in gown certification programs.
• Communicate aseptic processing concerns to management.
• Collaborate with Quality EDS systems (TrackWise, Master Control, MODA).

Skills

Aseptic processing knowledge

Word, Excel, PowerPoint

TrackWise

LMS

MasterControl

Regulatory compliance

Education

Bachelor of Science in Biology (Microbiology emphasis)

Tools

TrackWise

LMS

MasterControl

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Jubilant HollisterStier LLC in Spokane, WA is seeking a Senior Associate for Aseptic Process & Training to maintain and advance the aseptic training program. You will serve as SME on aseptic technique across Jubilant Manufacturing Facilities and lead training initiatives to ensure best practices in a regulated environment.

The role requires a BS in Biology (Microbiology) with 5+ years in aseptic processing, and hands-on experience with TrackWise, LMS, and MasterControl.