Under the direction of the Supervisor, the Clinical Solid Oral Dose Operator is responsible for all activities related to the blending, milling, compression and coating of the product as per formula instructions. Also, responsible for adhering to safety procedures, Standard Operating Procedures (SOPs) and Good Manufacturing Practices (cGMPs). Assist with facility cleaning and operational maintenance. Assist with process validations as required. Assist with environmental and water system monitoring as required. Assist with clean room sanitization as required. Other tasks as assigned by Supervisor.
Key Duties include: Operates manufacturing machinery independently as well as within a team environment. Maintain tablet press tooling. Actively participates in the continuous improvement of the procedures and processes. Monitors the process periodically and reports any abnormal conditions to the supervisor/manager. Complies with company policies and procedures and maintains regular work attendance. Personal responsibility for following safety rules, SOPs and cGMP guidelines. Performs other duties as assigned
Minimum Education & Experience Requirements:
High School diploma or equivalent. 1 years experience in Oral Solid Dosage pharmaceutical operation. Previous experience working with DEA controlled substances and highly potent compounds preferred. Previous experience repairing minor tooling defects, cleans, deburrs, polishes, or grinds metal items using a hand grinder preferred.
Ability to communicate clearly. Must be able to respond to and precisely follow verbal and written instructions Basic knowledge of the Scientific Method. Basic math skills, including simple algebra. Basic knowledge of and adherence to current GMP. Basic knowledge of chemistry and biology. Basic knowledge of HAZCOM, RCRA and other Safety requirements. Basic level of mechanical aptitude. Good documentation skills. Ability to lift / move 50 lbs. overhead. Physical ability to repetitively lift, stand, climb, bend, etc within a manufacturing environment. Ability to learn how to operate all types of production equipment (I.e. Honeywell DCS panels, CIP system, Process Waste system, etc.). Ability to read, understand and accurately follow company SOPs and guidelines.
Personal Attributes Needed:
Detail oriented. Willing to learn new tasks, skills. Works well in a team environment. Responds quickly to assignments. Readily adapts to changing job duties. Positive attitude. Displays understanding of and promotes company and customer objectives.