Manufacturing Associate

Role Summary

Responsibilities

• Proficient in aseptic processing including media exchanges, vessel passaging, harvest & cryopreservation of cells as required by the daily production schedule.
• Ability to complete and maintain aseptic gowning qualification, aseptic process qualification, and cleaning & disinfection qualification.
• Perform media and reagent preparation duties as required.
• Ability to operate and maintain equipment.
• Perform equipment preventative maintenance, cleaning/disinfection, and basic troubleshooting, as required.
• Perform, record and report various inventory tasks (i.e. consumables, media, cryovial, etc.)
• Ability to train others on support tasks, basic SOPs, equipment, and process operations.
• Achieves PowerUser status on supporting electronic systems (i.e., MasterControl).
• Follows, revises, executes, and authors SOPs and MBRs in accordance with cGMPs.
• Ability to author and review documentation and MBR’s at a high level.
• Ability to author and close quality items, including quality event investigations and deviations.
• Ability to initiate simple change controls and manage tasks required.
• Assists with material procurement and receipt.
• Maintains orderly and timely records of samples and data, in accordance with company policy and legal requirements.