Senior Aseptic Process & Training Specialist

Jubilant Pharma, LLC; Spokane, Northern (WA, KY); On-site; USD 44,000 - 52,000; Full time

Job summary

Jubilant HollisterStier Spokane is seeking an Aseptic Process & Training Sr. Associate to maintain the aseptic training program and act as the SME for aseptic practices across Jubilant Manufacturing Facilities.

You will disseminate current best practices through training, projects and auditing programs. The role requires a Bachelor's in Biology (microbiology emphasis), 5+ years in aseptic processing, pharmaceutical/FDA-regulated experience, and strong MS Office and Trackwise/MasterControl

Qualifications

• Bachelor's of Science, Major in Biology with emphasis in Microbiology.
• Minimum 5 Years Working in Aseptic Processing.
• Pharmaceutical Experience.
• FDA Regulated Industry Experience.
• Understanding of Aseptic Processing.
• Clean Room Behavior.
• Working Knowledge of Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Trackwise, LMS, and MasterControl.
• Provides Analysis, Diagnosis or Production Tasks Which Noticeably Impact End Results.

Responsibilities

• Maintain training and continuing education to serve as facility aseptic practices SME.
• Perform SOP review, auditing, training, and investigational responsibilities as needed.
• Be knowledgeable of current regulatory expectations of aseptic processing sites.
• Work with Regulatory and Compliance projects as required.
• Maintain aseptic training courses to ensure content is delivered effectively and reflects best practices.
• Deliver Aseptic training courses both initially to new hires and on a continuous basis to necessary roles.
• Own the aseptic processing SOP and ensure content is in alignment with current best practices.
• Perform aseptic behavior audits in all areas.
• Review output from internal and external auditing systems to ensure best aseptic practices are being followed. Develop and execute plans to mitigate gaps.
• Maintain gown certification.
• Participate in the gown certification program as aseptic SME.
• Communicate areas of concern with regards to aseptic processing to management.
• Work with Quality EDS systems such as Trackwise, Master Control, and MODA.
• Location: Spokane, WA — On Site, Full-Time.

Job description

Jubilant HollisterStier Spokane is seeking an Aseptic Process & Training Sr. Associate to maintain the aseptic training program and act as the SME for aseptic practices across Jubilant Manufacturing Facilities.

You will disseminate current best practices through training, projects and auditing programs. The role requires a Bachelor's in Biology (microbiology emphasis), 5+ years in aseptic processing, pharmaceutical/FDA-regulated experience, and strong MS Office and Trackwise/MasterControl