Machine Operator

Job Details

Job Location
MO - Earth City, MO

Position Type
Full Time

Education Level
High School Diploma or GED

Travel Percentage
None

Job Shift
Second Shift

Job Category
Manufacturing

Description

Job Title: Level 1 Operator

Department: Production

Reports To: Shift Supervisor

PRIMARY PURPOSE or JOB SUMMARY

The Level 1 Operatoroperates packaging equipment to ensure that safety, quality and output are optimized. The Level 1 Operatorshall fully comply with all regulatory / cGMP guidelines and Legacy Pharma Solutions 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 Legacy Pharma Solutions policies and procedures.
• Complies with all GMPs and SOPs in a FDA regulated pharmaceutical 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 Level 1 Operatorshall be held accountable for the compliance, accuracy and timeliness of responsibilities and work assigned.
• The Level 1 Operatorshall be held accountable for meeting job performance expectations.
• The Level 1 Operatorshall 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 Level 1 Operatorshall 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 Level 1 Operatorshall 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

Hourly, Non-exempt position

ADDITIONAL COMMENTS

Experience in a cGMP environment preferred