About this opportunity
Aequor lists this Manufacturing Associate opportunity in walkersville, Maryland. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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.
Scroll down to find the complete details of the job offer, including experience required and associated duties and tasks.
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. xzgxqkn 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.
Worksite address
walkersville, MD, 21793, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.