Manufacturing Associate Level 1

Title - Manufacturing Associate Level 1
Location - Walkersville MD
Duration - 6 Months (Possibility of extension)


Supervisory Organization*
Endotoxin Operations
Reports to (position)*
Supervisor
Job Title*
Manufacturing Associate I, Endotoxin
 
Job Description Summary
Provide a brief (3 – 4 sentence) description that states “why” the job exists and describes the nature and level of work.
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.
 
Key Accountabilities
Define all key accountabilities (5-10), which the role will be expected to perform in short to medium future. Make sure that you list the accountability on top, which the role will be doing most frequently and which has most impact on the the team/BU/Lonza. Begin each sentence with an action word, e.g. Provides appropriate coaching and performance feedback to all direct reports.
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.

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