Open Position for Manufacturing Technician I
The following is a description of the tasks and responsibilities for the Manufacturing Technician I position at Rebiotix Inc.
Reports to: Manufacturing Manager
Summary of position
The primary responsibility of the Manufacturing Technician I is to manufacture, package, and ship RBX2660 and other clinical and drug products following cGMP (current Good Manufacturing Practices). The Manufacturing Technician I will be responsible for executing protocols and batch records in accordance with Rebiotix policies, SOP’s, and work instructions. In addition to the basic job function, the Manufacturing Technician I will support other departments as responsibilities are assigned.
Primary Duties and Responsibilities
Perform lab duties as assigned, including collection, inspection, processing and testing, under the supervision of the lead and manager.
- Drug substance collection, inspection, and sampling
- Manufacturing of drug batches and placebo batches per batch records
- Preparation/shipment of outbound product and materials
Create and maintain documentation according to cGMP standards.
- Document, at the time of performance, all lab activities.
- Document abnormalities and other variations according to standards.
- Maintain files and documents per procedure.
Keep the lab and all lab equipment clean and organized according to equipment specifications and lab expectations.
- Clean, organize, and general up-keep of manufacturing areas as required.
- Clean manufacturing equipment according to manufacturer specifications.
Safety is each employee’s responsibility.
- Ensure your workspace is set-up and you use it in a way that will prevent injury or incident.
- When you see a hazard or potential hazard do something to correct it or notify the appropriate person to get it corrected.
- Report near-misses or incidents per the procedure as required.
Any other duties as assigned for business reasons.
Required & Preferred Qualifications
- Required 1-2 years of experience in a manufacturing lab setting.
- Required Experience with technical documents and technical reports
- Required Must be detailed oriented and able to follow specific work instructions
- Required Must be able to accurately perform calculations per batch records
- Required Must have excellent communications skills
- Required Experience with Microsoft Office, specifically Word and Excel
- Preferred cGMP manufacturing experience
- Preferred Experience in a controlled, regulated work environment