Position : Machine Operator I

Location : Burlington, NC

Duration : 12+ Months Contract

Total Hours/week : 40:00

Qualifications:

• Must have performed the Packaging Operator job function for a minimum of 12 months or have 3+ years of experience working in high-volume, FDA-regulated, and automated manufacturing
• High school diploma/GED
• Strong attention to detail
• Must be willing and/or able to work a flexible work schedule including static or rotating shifts and overtime as required
• Familiarity with computers for general business use
• Must be able to comprehend and follow written and verbal instructions in English
• Experience troubleshooting/optimizing manufacturing processes
• Demonstrated mastery of at least two BD-Sure Path™ manufacturing operations and the associated documentation, as established through supervisor evaluation/observation or 3+ years of experience operating similar processes in an FDA-regulated environment
• Ability to perform calculations to analyze process data for comparison to targets/metrics
• Ability to chart and interpret process data to detect and react to trends

Education and Experience Preferred:

• Associate’s Degree in a field related to manufacturing, biology, or business

Responsibilities:

• Utilize a variety of equipment and processes to generate finished goods for BD-SurePath™, BD-SurePath Plu, and ProEx™ C as required to satisfy all customer, internal, clinical, and other demand.
• Ensure finished product is manufactured in accordance with procedures and Quality specifications. Inspect in-process parts to ensure consistent quality and remove defective product, packaging, and component material.
• Responsible for ensuring timely and accurate documentation of all manufacturing activities, including but not limited to device history records and inventory counts.
• Perform simple mathematical calculations required to assist in completion of batch record.
• Monitor production lines, anticipating and reacting to problems. Notify supervision of deviations from normal operating conditions.
• Complete scheduled production runs in an efficient, timely manner to meet production schedules or maintain Kanbans.
• Utilize Kaizen Action Sheets on a regular basis to suggest and implement improvements to existing processes.
• Participate in Continuous Improvement projects or events as requested.
• Assist with inventory counting activities as required.
• Participate in safety audits as required and actively engage in daily safety discussions/observations.
• Perform routine cleaning of processing equipment.
• Abide by all personal protective equipment and product contamination control (i.e. gowning) requirements.
• Handle hazardous waste as appropriate.
• Assist with validation activities for new or modified processes and products.
• Assist with routine maintenance activities as necessary – this includes participation in Preventive Maintenance work and manufacturing line recovery
• Ensure all work instructions accurately reflect current processes; notify area lead in any instance where approved work instructions are inconsistent or inaccurate.
• Independently operate (or lead the operation of) all distinct manufacturing lines on a regular basis.
• Participate in Lean/Six Sigma activities on a regular basis to drive continuous improvement of Reagent processes/products.
• Assist with root-cause analysis activities for process, product, or inventory exceptions.