Manufacturing Operator

Job Responsibilities:

• Load and unload materials into machines based on the production plan, ensuring that all materials meet regulatory requirements and are in compliance with GMP (Good Manufacturing Practices).
• Check and verify raw materials to ensure they meet production specifications and quality standards before they are used in the production process. This includes identifying any discrepancies and escalating concerns to supervisors.
• Oversee material flow in and out of clean room environments, ensuring all production lines maintain high standards of cleanliness and organization. Support the team in maintaining continuous operation by promptly addressing any material or equipment issues that may arise.
• Perform routine maintenance on production equipment, ensuring machines are properly calibrated and operational. Address minor mechanical issues and perform necessary line clearances during production changeovers, following all Safety and Regulatory guidelines.
• Conduct regular in-process checks and document the results, ensuring products meet the required specifications and regulatory standards (eg, FDA, ISO 13485). Correct any deviations from production standards in Real Time and report issues promptly.
• Provide clear communication to the incoming shift regarding production status, issues, and any relevant updates. Ensure a smooth handover of responsibilities to maintain continuous production flow.
• Collaborate with cross-functional teams to maintain a culture of compliance and quality. Communicate regularly with supervisors and quality control teams to ensure adherence to all regulatory standards, resolve issues, and support quality initiatives.

Qualifications:

• Must comply with all safety regulations, promoting a Safety First culture in the workplace. PPE, such as safety glasses, safety shoes, hearing protection, and gowning, is required in designated areas.
• Ability to stand or sit for extended periods (up to 8 hours/day), frequently bend, twist, and reach as part of daily tasks. Capable of lifting, carrying, and moving items weighing up to 20 pounds.
• Completion of internal Quality Management System (QMS) training and corporate safety training.
• Must have 20/20 vision (natural or corrected) to perform visual inspection of products and ensure compliance with quality and regulatory specifications.