Manufacturing Associate

Manufactures human blood derived components per Standard Operating Procedures (SOPs) 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.

• - Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique
• - Knowledge of cGMP/FDA regulated industry
• - Basic mathematical skills - General understanding of cGMPs
• - Technical writing capability
  - Proficient in MS Office applications
• - Background to include an understanding of biology, chemistry, medical or clinical practices Pre-requisites:
  Entry
  - Level

• Production of blood component lots through cell culture, harvest, and cryopreservation.
• Aseptic technique is required for tube most activities: welding, connections, and transfers, at minimum.
• 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.
• 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.
• Leads a team within a designated function of manufacturing, however, supervision will be managed by the shift Supervisor.
• No direct reports will be assigned to this job role.
• Performs other tasks as assigned.

This position takes place in a GMP clean room environment, which includes being gowned for up to 6 hours. During the processing time in the clean room, no breaks may be taken

• - Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.
  
  - Physical dexterity sufficient to use computers and documentation.
• Sufficient vision and hearing capability to work in job environment.
• Ability to lift up to 25 pounds.
• Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
• Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
• Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
• Flexibility to don clean room garments and personal protective equipment (PPE).
• Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected.
• Routine exposure to human blood components.
• Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum.