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.

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Operating in a safe work culture (safety chats, safety and EPS observations, 6S)Completion of LAL Cleanroom General TrainingAseptic processing/gowningCleanroom Equipment Set-Up and UsageEnvironmental MonitoringQualification of SAP Transactions (COR3, COR6, MIGO, LS26)Completion of LAL Finishing General TrainingFinishing Equipment Set-Up and UsageQualification of SAP Transactions (COR2, COR6, MIGO, MB1A, LB01, LS26)GMP Documentation practicesProduct Sample SubmissionInspection Proficiency TestingInspection ProcessComponent Kitting ProcessContinuous Improvement ProjectsPerform job functions with minimal operator related PRsPerform aseptic processing with minimal operator related personnel excursions (EM)Understand basic level of LAL process flowAchieve yearly personnel utilization targetMaintain training compliance to meet yearly targetMust be able to demonstrate GMP documentation practices (minimal document errors)Must be able to follow standard operating procedures and complete production recordsUnderstand compliance in the execution of GMPs in a manufacturing environmentComply with all safety policies and general regulationsPerform 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.
SkillsKnow-HowCompletes standard tasks by applying basic principles and through research and interpretation of factual informationImpacts through accuracy of tasks and information provided (90% accuracy)Contributes to team and builds stable internal department and inter-departmental and external working relationshipsGeneral technical & scientific knowledgeBasic process knowledgeBasic math skillsBasic Computer skillsFamiliarity with lab techniques and practices (Basic GMP and GDP)Problem SolvingWorks on problems of limited scopeUses minimal discretion to complete basic tasksMinimal troubleshooting – follows instructionsGuided by production schedule, goals and objectives.Follows product specific standards, protocols and/or processesRely on team for direction (i.e. work assigned by scheduler)Work is closely monitored
Impact on KPI’sIndividual contributorNo spending budget, using pre-defined purchasing approval processSize & ScopeNo direct or indirect reportsDeals with issues of low complexity / high volumeWorks under direct supervision
Adherence to cGMPs is required at all times during the manufacture of APIs. xzbcwsv 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.