Manufacturing Associate Level 1

Notes from Intake call:

Looking for potentially 2 people. Role(s) will begin with working in the kitting and labeling department, packaging and labeling 2-30mL vials. Someone with 1 year of experience with Good Document Practices would be ideal so that they have a basic understanding. As the role evolves and based on performance, tehre will be opoetunities to move into higher level positions within manufacturing, and/or move to 3rd shift. There are built in pay increases for both 3rd shift and becoming gown qualified. Plenty of overtime will be available, but is not mandatory. Standard shift begins at 7:30AM for a daily meeting, and will end at 4PM, Monday through Friday.

Responsible for participating in upstream and/or downstream aseptic manufacturing of LAL products in a ISO 5 environment according to company and departmental SOPs. Performs set-up and operate production equipment in the LAL Filling and Finishing areas. Performs product inspections and final kit packaging of finished goods.

• Operating in a safe work culture (safety chats, safety and EPS observations, 6S)
• Completion of LAL Cleanroom General Training
• Aseptic processing/gowning
• Cleanroom Equipment Set-Up and Usage
• Environmental Monitoring
• Qualification of SAP Transactions (COR3, COR6, MIGO, LS26)
• Completion of LAL Finishing General Training
• Finishing Equipment Set-Up and Usage
• Qualification of SAP Transactions (COR2, COR6, MIGO, MB1A, LB01, LS26)
• GMP Documentation practices
• Product Sample Submission
• Inspection Proficiency Testing
• Inspection Process
• Component Kitting Process
• Continuous Improvement Projects
• Perform job functions with minimal operator related PRs
• Perform aseptic processing with minimal operator related personnel excursions (EM)
• Understand basic level of LAL process flow
• Achieve yearly personnel utilization target
• Maintain training compliance to meet yearly target
• Must be able to demonstrate GMP documentation practices (minimal document errors)
• Must be able to follow standard operating procedures and complete production records
• Understand compliance in the execution of GMPs in a manufacturing environment
• Comply with all safety policies and general regulations
  Perform other duties as assigned