Manufacturing Associate Level 1

Description:
Working in the kitting and labeling department, packaging and labeling 2-30mL vials. Someone with 1 year of experience with Good Document Practices would be ideal so that they have a basic understanding. As the role evolves and based on performance, there will be opportunities to move into higher level positions within manufacturing, and/or move to 3rd shift . Plenty of overtime will be available, but is not mandatory. Standard shift begins at 7:30AM for a daily meeting, and will end at 4PM, Monday through Friday.

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.

Responsibilities:
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.

EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.