Job Description
Job Description
Dispensing and Manufacturing
This role is responsible for the dispensing of raw materials (liquids and powders, hazardous and non-hazardous, acids and bases) under cGMP conditions. The purpose is to support the manufacture of therapeutic proteins (API).
The individual must perform and monitor all dispensing processes and weighs. All processes will be completed according to cGMP guidelines to ensure the successful manufacture of therapeutic proteins (API).
Core Responsibilities
cGMP & Safety: Attain a basic understanding of cGMP compliance, including aseptic technique and awareness of cross contamination. This work is performed while gowned and wearing required PPE in a Class C environment.
Following Procedures: Adhere to all written procedures (SOPs), execute process recipes, and monitor equipment and processes.
Laboratory Tasks: Perform basic laboratory tasks such as checking pH, conductivity, and sampling.
Documentation: Report to production using written and electronic documents in accordance with cGMP and GDPs. This includes performing documentation reviews.
Equipment Maintenance: Qualify for all assigned tasks and maintain an individual training plan. This includes qualifying to perform required functions and scheduled cleans on all Dispensing equipment through routine cleaning and sanitization.
Material Handling: Prepare materials for transport to manufacturing suites. Perform material movements both physically and in software systems.
Administrative & Team Support
Reviews: Perform peer, First Level Reviews of completed eDispense orders/kits after completing WBT and LQM/PM sign-off.
Safety: Participate in Safety Inspections and submit safety observations.
Administrative Tasks: Attend shift exchange and meetings, manage emails, and participate in assigned projects.
Logistics: Perform other duties as assigned to support the Logistics Team.
You should be proficient in:
- Hazardous Materials
- Equipment Troubleshooting
- Machine Safety Inspections
- Experience in a Manufacturing Environment