Machine Operator I

About the role

Contract position in Burlington, NC, working 9:00 PM to 7:00 AM, Monday through Thursday, for a total of 40 hours weekly. Pay rate is $13/hr.

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-SurePath™ 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 Plus, 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

Job Dimensions

• Works on assignments that are semi-routine in nature where ability to recognize and assist in recovery from deviation from specification is required
• Performs routine work with virtually no supervisory input and new assignments with detailed instructions from supervision
• Interacts daily with other employees within Reagent Manufacturing to ensure robust understanding of current activities across the department
• Operates independently within the constraints of approved process-related documentation
• Interacts daily with counterparts in Quality Control to ensure open communication lines to maximize process efficiency and product quality
• Assists in the development and training of Packaging Operators to build their skill-sets beyond entry-level tasks
• Trains or seeks training on new and revised procedures to maintain currency on all areas of job scope