Duties:

• R esponsible for various tasks, such as cleaning, sanitization, preparation, and fulfilling products for commercial and clinical use.
• Perform document review, including executed Batch Records and Logbooks.
• Support documentation needs, which include a review of SOPs, Batch Records, Deviations, CAPAs, etc.
• Supports technical transfer and additional research-level testing activities as needed
• May support training sessions as a qualified trainer, ensuring training documentation is maintained.

Qualifications:

• Minimum 2 years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA
• Preferably with experience in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operation