U-09 Manufacturing Excellence Operator III- 2nd Shift

Role Responsibilities

• Follow all aseptic/sterile/cGMP techniques.
• Continually meet cleanroom gowning requirements and adhere to aseptic technique principles.
• Check clean room/filling processes to ensure compliance with cGMP and departmental procedures.
• Report any problems to the department supervisor.
• Sanitize Clean Room areas in accordance with applicable procedures.
• Assure drug and raw materials (RMP’s and RMC’s) accountability is maintained.
• Review and perform as required, proper accountability, documentation and quality in-process test results as required per the applicable SOP or Batch Record (and logbooks).
• Unload sterilizers and properly handle components, receive components, verify counts, and assign to respective batches.
• Prepare solutions for other departments.
• Perform appropriate housekeeping duties per SOP’s.
• Operate any/all assigned machines and/or equipment and aseptically hand assemble components.
• Clear jams and perform tabletop adjustments required on equipment.
• Setup, tear down and changeover all Clean Room isolated machinery, and perform tabletop adjustments required on equipment.
• Complete and maintain all training requirements for position and show proficiency in required job functions.
• Participate in continuous improvement event/activities.
• Assist maintenance technicians with equipment issues.
• Operators will be required to perform operator / asset care of equipment as assigned.
• Perform other duties as assigned.

Basic Qualifications

• High school diploma or general education degree (GED) with a minimum of 2 years of related experience; Associates or Technical Degree preferred.
• Able to read and comprehend instructions, correspondence, and technical documents.
• Able to effectively present information in one-on-one and small group situations to other employees of the organization.
• Able to perform calculations for percent accountability, reconciliation of numerical values and bulk density calculations.
• Proficient in operating computerized systems and software.
• Able to follow and review detailed documentation for accuracy and completeness.

Technical Qualifications

• Able to clear jams and perform tabletop adjustments required on equipment.
• Able to setup, tear down and changeover all Clean Room isolated machinery.
• Ability to wear a respirator and pass respirator training.
• Able to pass gowning training and become gown qualified to enter the Aseptic area.
• Experience participating in continuous improvement events/activities is a plus.

Physical Qualifications

• Regularly required to use hands to finger, handle, or feel objects, tools, or controls.
• Regularly required to stand and walk; climb or balance; and stoop, kneel, or crouch.
• Occasionally lift and/or move up to 60 pounds.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust and focus.
• Must wear all required safety equipment and perform assigned work in a safe manner.
• Must use proper lifting techniques and be conscious of hazards around him/her.
• Must follow all GMP and safety procedures within the department.

Occupational Exposure/Risk Potential

• Work environment includes the ability to work with high potent chemical compounds, hazard materials, toxics, and control substances.
• Willingness to adhere to stringent PPE requirements, safe work methods and practices for personal and product protection.
• Attention to detail instructions and following other safe practices are key requirements as well.
• Medical surveillance protocols and questionnaires may be part of some of the products to be manufactured.