This job is onsite 5 days a week. You will be working Night shifts from 7:00 pm -7:00 am. 1 year contract with extension.
Responsible for the dispensing of raw materials liquids and powders (hazardous and non-hazardous), acids/bases, under cGMP conditions to support the manufacture of therapeutic proteins (API)
Individual will be required to perform and monitor all dispensing processes and weighs, including liquid, powder (hazardous and non-hazardous), acids and bases. All processes will be completed per cGMP guidelines to support the manufacture of therapeutic proteins (API).
• Required to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique and cross contamination awareness in handling of products and materials.
• Expected to follow and adhere to all written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, and sampling as required. All tasks will be completed while gowned and wearing required PPE while working in a Class C environment.
• Expected to execute process recipes.
• Ability to qualify for all assigned tasks and maintain individual training plan.
• Ability to qualify and perform required functions and scheduled cleans on all Dispensing equipment through routine cleaning and sanitization.
• Perform peer, First Level Reviews of completed eDispense orders/kits, upon completion of WBT and LQM/PM signoff by area trainer.
• Ability to report to production via written and electronic documents in accordance with current good manufacturing practice (cGMP) and good documentation practice (GDPs). Complete documentation reviews as appropriate.
• Prepare materials for transport and delivery to manufacturing suites. Perform material movements both physically and in software systems.
• Participate in Safety Inspections and submit safety observations to provide safer working conditions for self and others.
• Administrative tasks to include attendance at shift exchange and required meetings, sending/receiving of emails, and participation in assigned projects.
• Performs other duties as they are assigned to support Logistics Team.
Associates Degree and/or equivalent experience
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