Purpose

Describe the primary goals, objectives or functions or outputs of this position.

Perform cleaning, sterilization, weighing and dispensing of materials. Monitor alarm systems. Assemble and inspect equipment in the manufacturing area to confirm operational status. Work is performed in aseptic or non-aseptic environments. Perform process tests and participate in qualification and validation activities as required.

Responsibilities

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• Inspect manufacturing equipment to monitor that performance is within parameters.
• Clean and sterilize equipment for manufacturing use.
• Monitor manufacturing processes using electronic or manual systems and elevate any deviation that could impact the operations to address accordingly.
• Sample collection and processing as required by the process.
• Conduct equipment and facility inspections and advise of situations that affect operating and environmental conditions.
• Receive, inspect and verify materials availability to be used for production.
• Document, audit and timely correct manufacturing electronic or paper batch record discrepancies. Document process and equipment status in the area electronic or manual records.
• Audit documentation of operational activities and document discrepancies using computerized or manual systems.
• Strict adherence to current Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP) and accurately complete process-associated documentation.
• Provide assistance to operations in accordance with environmental management, occupational health and safety (EHS) systems and promote continuous improvement. Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal, and any other program applicable according to the position duties.