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H

Manufacturing Associate Level 1

HireTalent
  • 🇺🇸 United States
  • On-site
  • 12 hours ago
  • SAP
  • GMP
12 hours ago
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Job Title: Manufacturing Associate Level 1
Location: Walkersville, MD
Duration: 06 Months on W2.

Shift: Standard shift begins at 7:30AM for a daily meeting, and will end at 4PM, Monday through Friday.

Job Description:
  • 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:
  • 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.
Skills:
Know-How
  • Completes standard tasks by applying basic principles and through research and interpretation of factual information
  • Impacts through accuracy of tasks and information provided (90% accuracy)
  • Contributes to team and builds stable internal department and inter-departmental and external working relationships
  • General technical & scientific knowledge
  • Basic process knowledge
  • Basic math skills
  • Basic Computer skills
  • Familiarity with lab techniques and practices (Basic GMP and GDP)
Problem Solving
  • Works on problems of limited scope
  • Uses minimal discretion to complete basic tasks
  • Minimal troubleshooting – follows instructions
  • Guided by production schedule, goals and objectives.
  • Follows product specific standards, protocols and/or processes
  • Rely on team for direction (i.e. work assigned by scheduler)
  • Work is closely monitored
Impact on KPI’s
  • Individual contributor
  • No spending budget, using pre-defined purchasing approval process
Size & Scope
  • No direct or indirect reports
  • Deals with issues of low complexity / high volume
  • Works under direct supervision

Manufacturing Associate Level 1 · HireTalent

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