The Production Technician, acting under direct supervision, assists in all phases of clinical packaging, labeling, manufacturing, and assembly of investigational drug product that includes but is not limited to blistering, bottling, carding, encapsulation, manufacturing, labeling, and assembly. He/She prepares and completes packaging supplies and required documentation in accordance with approved manufacturing instructions (MIs), company SOPs and cGMP Regulations.
Essential Duties and Responsibilities
- Execute packaging of clinical supplies as determined by the approved manufacturing instructions in accordance with company SOPs and cGMP Regulations.
- Complete support documentation associated with the execution of the packaging operation(s) being performed.
- Ensure that packaging areas are maintained in accordance with company SOPs and cGMP regulations before, during, and after any packaging operation.
- Able to operate and become familiar with packaging equipment.
- Responsible for general housekeeping of packaging, labeling, assembly, and manufacturing areas.
- Responsible for cleaning of cGMP packaging areas, equipment and utensils on an as needed basis.
- Adhere to set safety standards.
- Participate actively in regular meetings.
- Achieve expected performance measures.
- Other duties as assigned.
