Manufacturing Operations Specialist - LanceSoft Inc
Morris Plains, NJ 07950
About the Job
Manufacturing Operations Specialist
Location: On-Site - Morris Plains, NJ
Pay Rate: *** - ***
The Manufacturing Operations Specialist is responsible for the Dispensary / ISO8 area tasks including kitting and material flow, inventory management and other duties required to support the core functions.
Key Responsibilities:
" Adhere to all area governing SOPs, WPs, and batch records with a focus on Right First-Time performance. Ensure accurate SAP/MES inventories are maintained for all components.
" Ensure Manufacturing Support areas are maintained in an audit ready state.
" Ensure equipment cleaning and maintenance is performed per governing SOP requirements.
" Escalate any observed compliance or safety issues and support reconciliation of event.
" Proficient in various operating systems, including but not limited to LIMS, SAP, MES etc.
" Support monthly and annual cycle count and support all site/team projects and initiatives.
" Coordination of receiving, storage and processing of materials.
" Ensure inventory accuracy of GMP and non-GMP LN2 storage locations.
Dispensary / ISO8 Activities:
" Ensure accurate SAP/MES inventories are maintained for all components.
" Ensure proper status segregation and storage of all conditioned and ambient materials.
" Ensure Kanban system is accurate, and materials are consumed per FEFO/FIFO.
" Ensure kitting/staging of initial kits are complete for each shift and timely response to kitting requests for production.
" Monitor staged kits for expired materials and to ensure utilization prior to expiry.
" Ensure all gowning materials in the ISO8 staging area are maintained to adequate levels.
" Ensure dispensary area has ample supply of non-BOM items.
Alternate shifts, weekends and overtime will be required as needed.
Role Requirements:
" 1-3 years of related experience in cGMP/FDA regulated industry; warehouse experience preferred. High School degree required. Bachelor's degree preferred.
" Strong interpersonal, written and communication skills along with problem solving and follow-up skills are required.
" Must be well organized, flexible and work with minimal supervision.
" Ability to lift up to 50 lbs., assisted.
" Requires handling of chemicals such as corrosives, solvents & bio-hazardous material.
Shift Schedule:
Rotational shift (workdays to be determined)
Location: On-Site - Morris Plains, NJ
Pay Rate: *** - ***
The Manufacturing Operations Specialist is responsible for the Dispensary / ISO8 area tasks including kitting and material flow, inventory management and other duties required to support the core functions.
Key Responsibilities:
" Adhere to all area governing SOPs, WPs, and batch records with a focus on Right First-Time performance. Ensure accurate SAP/MES inventories are maintained for all components.
" Ensure Manufacturing Support areas are maintained in an audit ready state.
" Ensure equipment cleaning and maintenance is performed per governing SOP requirements.
" Escalate any observed compliance or safety issues and support reconciliation of event.
" Proficient in various operating systems, including but not limited to LIMS, SAP, MES etc.
" Support monthly and annual cycle count and support all site/team projects and initiatives.
" Coordination of receiving, storage and processing of materials.
" Ensure inventory accuracy of GMP and non-GMP LN2 storage locations.
Dispensary / ISO8 Activities:
" Ensure accurate SAP/MES inventories are maintained for all components.
" Ensure proper status segregation and storage of all conditioned and ambient materials.
" Ensure Kanban system is accurate, and materials are consumed per FEFO/FIFO.
" Ensure kitting/staging of initial kits are complete for each shift and timely response to kitting requests for production.
" Monitor staged kits for expired materials and to ensure utilization prior to expiry.
" Ensure all gowning materials in the ISO8 staging area are maintained to adequate levels.
" Ensure dispensary area has ample supply of non-BOM items.
Alternate shifts, weekends and overtime will be required as needed.
Role Requirements:
" 1-3 years of related experience in cGMP/FDA regulated industry; warehouse experience preferred. High School degree required. Bachelor's degree preferred.
" Strong interpersonal, written and communication skills along with problem solving and follow-up skills are required.
" Must be well organized, flexible and work with minimal supervision.
" Ability to lift up to 50 lbs., assisted.
" Requires handling of chemicals such as corrosives, solvents & bio-hazardous material.
Shift Schedule:
Rotational shift (workdays to be determined)
Source : LanceSoft Inc
