Manufacturing Excellence Operator- 2nd Shift

Role Responsibilities

• Follow all aseptic/sterile/cGMP techniques.
• Continually meet cleanroom gowning requirements and adhere to aseptic technique principles at all times inside the Processing Area.
• Check clean room/filling processes to ensure compliance with cGMP and departmental procedures and 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).
• 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

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