Manufacturing Associate

Job Title - Manufacturing Associate I, Endotoxin

Job Location – Walkersville, MD

Job ID : 1671

Duration : 6 Months+

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.

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.

Quality:

Adherence to cGMPs is required at all times during the manufacture of APIs. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.

Safety:

Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site.

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

Adherence to cGMPs is required at all times during the manufacture of APIs. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.