Production Room Leader - 1st Shift

Job description

The Clinical Supplies Room Leader, acting under direct supervision, executes and oversees 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 (MI’s), company SOP’s and cGMP Regulations. ESSENTIAL DUTIES AND RESPONSIBILITIES: - Execute packaging of clinical supplies as determined by the approved manufacturing instructions (MI’s) in accordance with company SOP’s 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 SOP’s and cGMP Regulations before, during, and after any packaging operation. - Able to operate packaging equipment. - Train Clinical Supplies Packaging Technicians on job specific duties. - Monitor Clinical Supplies Packaging Technicians in assigned packaging area to ensure compliance with company SOP’s, manufacturing instruct...