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
Numbers & Facts
Location
Walkersville, MD
Skills
Asepsisunmatched
Budgetingunmatched
Cleanroomunmatched
Computer Skillsunmatched
Continuous Improvementunmatched
Data Qualityunmatched
Documentationunmatched
Environmental Monitoringunmatched
GMP (Good Manufacturing Practices)unmatched
ISO (International Organization for Standardization)unmatched
Identify Issuesunmatched
Laboratory Techniquesunmatched
Manufacturingunmatched
Mathematicsunmatched
Process Flowunmatched
Production Scheduleunmatched
Public/Media/Press/Analyst Relationsunmatched
Purchasing/Procurementunmatched
Regulationsunmatched
SAPunmatched
Safety Complianceunmatched
Safety/Work Safetyunmatched
Schedule Developmentunmatched
Standard Operating Procedures (SOP)unmatched
Testingunmatched
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