Laboratory Operations Associate

Description

As a Laboratory & Operations Associate, you will be responsible for performing a wide variety of lab operation procedures and analysis of biological specimens. This involves isolating and manufacturing fresh and cryopreserved cell-based products from healthy blood and bone marrow specimens, while keeping quality control specifications and internal Standard Operating Procedures (SOPs) at top of mind. This role is also responsible for providing Quality Control expertise in support of manufacturing operations and providing accurate and efficient logistical support for the movement, storage, control and protection of raw materials, supplies, work in process products, and finished goods.

Duties and Responsibilities:

• Perform cell processing and analysis on human blood, using a variety of laboratory instruments and techniques in accordance to the established SOPs, Federal and State regulations, and Good Laboratory Practices (GLP)
• Accurately complete batch records by carefully receiving, recording, and processing all materials, specimens, and reagents for order requests using the Laboratory Information Management System
• Conduct routine monitoring, inventory, and quality control of laboratory equipment, temperature controlled units and working conditions, including equipment maintenance and calibration
• Work with cross functional teams in production planning, and making process improvements
• Conduct routine QC release assays such as cell count, viability & purity
• Conduct Batch Record reviews and Material Disposition for Fresh shipments
• Works with cross-functional teams (Manufacturing Operations, Donor Center and Quality Assurance) to receive, inspect, release, store, monitor, issue materials internally, and ship Finished Goods to customers.
• Ensures final disposition of materials and finished goods take place as per established processes and procedures.
• Schedules and performs cycle count activities, and ensures counts are carried out accurately and on schedule.
• Record and transact all orders and maintain inventory on ERP system

Description

As a Laboratory & Operations Associate, you will be responsible for performing a wide variety of lab operation procedures and analysis of biological specimens. This involves isolating and manufacturing fresh and cryopreserved cell-based products from healthy blood and bone marrow specimens, while keeping quality control specifications and internal Standard Operating Procedures (SOPs) at top of mind. This role is also responsible for providing Quality Control expertise in support of manufacturing operations and providing accurate and efficient logistical support for the movement, storage, control and protection of raw materials, supplies, work in process products, and finished goods.

Duties and Responsibilities:

• Perform cell processing and analysis on human blood, using a variety of laboratory instruments and techniques in accordance to the established SOPs, Federal and State regulations, and Good Laboratory Practices (GLP)
• Accurately complete batch records by carefully receiving, recording, and processing all materials, specimens, and reagents for order requests using the Laboratory Information Management System
• Conduct routine monitoring, inventory, and quality control of laboratory equipment, temperature controlled units and working conditions, including equipment maintenance and calibration
• Work with cross functional teams in production planning, and making process improvements
• Conduct routine QC release assays such as cell count, viability & purity
• Conduct Batch Record reviews and Material Disposition for Fresh shipments
• Works with cross-functional teams (Manufacturing Operations, Donor Center and Quality Assurance) to receive, inspect, release, store, monitor, issue materials internally, and ship Finished Goods to customers.
• Ensures final disposition of materials and finished goods take place as per established processes and procedures.
• Schedules and performs cycle count activities, and ensures counts are carried out accurately and on schedule.
• Record and transact all orders and maintain inventory on ERP system

Skills

Laboratory, cell culturing, cell based assay,…