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PRIMARY PURPOSE or JOB SUMMARY
The Machine Operator operates packaging equipment to ensure that safety, quality and output are optimized. The Machine Operator shall fully comply with all regulatory / cGMP guidelines standards and policies. Contributes to a safe, customer-centric, and positive work environment that is focused on meeting the performance expectations of customers and ownership.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Communicates with each stakeholder with respect and dignity.
Demonstrates dependability and a commitment to the organization and team by maintaining an acceptable attendance record.
Complies with all safety policies and procedures. Reports all potential hazards, as well as unsafe behaviors, to management.
Demonstrates a working knowledge of cGMPs, FDA and DEA regulations and policies and procedures.
Complies with all GMPs and SOPs in a FDA regulated manufacturing environment, ensuring product integrity, safety and compliance with standards.
Responsible for the start-up, operation, and shutdown of all packaging line equipment. Will maintain and optimize existing packaging equipment to meet quality and customer expectations.
Performs changeover tasks on packaging line equipment.
Ensures that packaging line equipment is kept clean and that housekeeping in the area is maintained at an acceptable standard.
Works with a sense of urgency and pays attention to detail to minimize errors and to achieve the goals and objectives of the organization.
Ensures all assigned shift paperwork and batch record entries are completed in a timely and accurate manner. This includes proper measuring and reporting of performance metrics or reporting of downtime.
Participates in continuous improvement of the production/packaging process with members of management and other team members to drive wastes out of processes.
Provides feedback to the shift supervisor and other team members to identify and reduce wastes in process to optimize efficiencies and to drive down operating expenses; including major and minor changeovers.
Supports and participates in making line improvements and promote a team environment within the team. Supports and participates in continuous improvement activities, including leadership of 5S and kaizen events.
Fosters a team environment that is task-focused and minimizes conflict within the team.
Takes ownership and accountability for assigned job tasks and ensures that tasks are executed with a sense of urgency and a level of attention to detail.
Performs assigned job duties to ensure that production standards for output, changeovers/cleans/setups, labor and waste in all assigned areas meet or exceed company goals/ targets.
Cooperates with investigations regarding safety, security, regulatory compliance, and audit corrective actions.
Attends and actively participates in all mandatory meetings and activities.
Assists in training new operators.
Performs other duties as required by business needs.
ACCOUNTABILITY
The Machine Operator shall be held accountable for the compliance, accuracy and timeliness of responsibilities and work assigned.
The Machine Operator shall be held accountable for meeting job performance expectations.
The Machine Operator shall be held accountable for meeting compliance requirements, including cGMP, housekeeping and documentation. This includes batch a high level of accountability for batch record errors or falsification of documentation.
The Machine Operator shall be held accountable for supporting the Shift Supervisor in developing and maintaining a capable, motivated team of which positive communication and customer-centricity are a part of the team norms and culture. Developing and maintaining the team includes the ensuring that team members complete documented training to be proficient at his or her job tasks.
The Machine Operator shall be held accountable for adherence to policies and standard operating procedures, including the attendance policy.
SUPERVISORY RESPONSIBILITIES
None
QUALIFICATIONS
High school diploma or GED equivalent.
3+ years experience in a high volume, fast paced packaging or production environment.
Experience and working knowledge of 5S, SMED, gemba walks, LEAN tools, and the DMAIC process is preferred.
Must possess the verbal and written communication skills necessary to perform job duties and to comply with regulatory requirements.
Detail-oriented.
Ability to train others.
Flexibility to work any shift, as assigned by management.
Flexibility to work weekends and holidays, if required by business needs.
Able to stand and walk for 8+ hours.
Able to lift up to 25 lbs.
WORKING CONDITIONS
Production areas and/ or warehouse setting
