Production Operator II (Glasgow, KY)

• Responsible for verification of materials and products as directed by procedures and/or batch record requirements.

• Responsible for labeling, inspecting, and production of final container products with manual and/or automated systems.

• Responsible for set-up, changeover, and operation of labeling and production equipment.

• Responsible for data entry and computer-generated labels.

• Maintains records and production area to comply with regulatory requirements, good manufacturing practices, and standard operating procedures.

• Performs reconciliation activities and determines compliance to specification, floats on all lines.

• Performs final production check of completed documents for completeness and accuracy.

• Review of completed batch records for compliance with cGMPs ( current Good Manufacturing Practices ), validation, and standard operating procedure requirements.

• Reconciles labeling and product components to determine compliance with specifications.

• Assists in investigation of non-confirming results related to either reconciliation or production activities.

• Maintenance of logs, batch records, and all applicable documentation in accordance with cGMP specifications and internal standard operating procedures.

• Maintain qualification to clean and verify thermoforming equipment, perform on-line product inspections, off-line inspections, and leak testing in accordance with qualification requirements.

• Ability to perform at or above established quality and productivity standards on all lines.