Manufacturing Associate, Manufacturing Operations - Summit West, NJ
VetJobs, Summit, NJ, United States
Manufacturing Associate, Cell Therapy
Our Manufacturing Associate, Cell Therapy team manufactures human blood derived components per Batch Record and Standard Operating Procedures in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable.
Shift Available: Quad 2: Sunday - Wednesday (with e/o Wednesday off), Onsite Overnight Shift, 5 p.m. - 5:30 a.m.* Start and end times are subject to change based on business demands.
Responsibilities:
Perform set-up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation.
Support deviation investigations and write ups as needed.
Support on time closure of any assigned CAPAs within the designated shift.
Aseptic technique is required for tube most activities: welding, connections, and transfers, at minimum. Aseptic qualification is required.
Weighs and measures in-process materials to ensure proper quantities are added/removed.
Adheres to the production schedule ensuring on-time, internal production logistics.
Records production data and information in a clear, concise, format according to proper GDPs.
Perform all tasks in a manner consistent with site safety policies, quality systems, and GMP requirements.
Works in a team based, cross-functional environment to complete production tasks required by shift schedule.
Motivated, team consciousness individuals are needed to fulfill job requirements.
Become a SME and qualified trainer within a designated function of manufacturing. Supervision will be managed by the shift Supervisor or designated Team Lead.
Maintain on time completion of training assignments to maintain the necessary technical skills and process knowledge.
Performs other tasks as assigned: continuous improvement projects, inspection readiness, right first-time initiatives, etc.
Our Manufacturing Associate, Cell Therapy team manufactures human blood derived components per Batch Record and Standard Operating Procedures in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable.
Shift Available: Quad 2: Sunday - Wednesday (with e/o Wednesday off), Onsite Overnight Shift, 5 p.m. - 5:30 a.m.* Start and end times are subject to change based on business demands.
Responsibilities:
Perform set-up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation.
Support deviation investigations and write ups as needed.
Support on time closure of any assigned CAPAs within the designated shift.
Aseptic technique is required for tube most activities: welding, connections, and transfers, at minimum. Aseptic qualification is required.
Weighs and measures in-process materials to ensure proper quantities are added/removed.
Adheres to the production schedule ensuring on-time, internal production logistics.
Records production data and information in a clear, concise, format according to proper GDPs.
Perform all tasks in a manner consistent with site safety policies, quality systems, and GMP requirements.
Works in a team based, cross-functional environment to complete production tasks required by shift schedule.
Motivated, team consciousness individuals are needed to fulfill job requirements.
Become a SME and qualified trainer within a designated function of manufacturing. Supervision will be managed by the shift Supervisor or designated Team Lead.
Maintain on time completion of training assignments to maintain the necessary technical skills and process knowledge.
Performs other tasks as assigned: continuous improvement projects, inspection readiness, right first-time initiatives, etc.