Manufacturing Associate II, Upstream

Job Description

Job Description

Description : SUMMARY

Under supervision, the Manufacturing Associate II, will perform routine manufacturing activities in GMP manufacturing areas including solution preparation, fermentation and / or cell culture and the associated sub- processes / preparation. Operations will be performed according to Standard Operating Procedures (SOPs) and batch records. Perform manufacturing steps, execute routine batch records, and revise documents such as batch records and SOPs as needed. Flexible shift schedules and overtime may be required.

JOB RESPONSIBILITIES

Essential

• Initiate Quality Events – IRs, DEVs, and OOTs.
• Set-up, operate, maintain and clean bioprocessing equipment.
• Demonstrate good aseptic technique.
• Basic troubleshooting of bioprocess equipment.
• Perform manual cleaning and sterilization of parts and components.
• Accurately complete and maintain detail-oriented process-related documentation of equipment logs and batch records following the good manufacturing documentation practices.
• Address production issues and report any compliance related concerns to supervisor.

Supplementary Responsibilities

JOB REQUIREMENTS

Education and Experience Required

Knowledge, skills and abilities

Requirements :