Job Description

Job Description: Our manufacturing company is seeking a team member to join our Reagent Small Vial Value Stream team. In this role you will formulate, fill, test, and package chemical and biological reagent products of varied complexity according to operational plans and customer demand. We're looking for associates whom thrive in a team-oriented, goal focused environment. We operate using Daily Management principles, providing immediate guidance and feedback to our associates and focusing on daily, monthly, and quarterly objectives. You'll be responsible for following established operation procedures, maintaining appropriate training records for your role, sustaining a smooth flow of material and the execution of work orders to on-time completion.

KEY RESPONSIBILITIES:
• Read and follow established work instructions and procedures with emphasis on quality (IN ENGLISH).
• Follow engineering drawings, work order information, SOPs, and other written and verbal specifications in the manufacturing process while maintaining FDA requirements (IN ENGLISH)
• Independently execute work regarding formulating, filling, testing and packaging.
• Apply basic analytical skills or scientific methods to perform daily tasks.
• Perform the set-up, calibration, testing and troubleshooting of reagent components and instruments.
• Conduct testing on solutions which include pH, conductivity, and density, to ensure adherence to production/process specifications.
• Assure compliance with FDA Quality System Regulations (QSR), Good Manufacturing Practices (GMP), and ISO regulatory requirements.
• Work directly and cooperatively with cross-functional team members to troubleshoot issues and ensure emphasis on quality.
• Identify, recommend and implement quality improvements including but not limited to production methods, equipment performance, product quality and efficiencies.
• Learn and participate in the company's lean manufacturing principles.
• Maintain a safe and clean working environment by complying with procedures, rules, and regulations.
• Perform other duties and cross training as assigned. Train new team members on equipment operations and work procedures as needed.
• Ability to complete appropriate paperwork, maintain accurate records of production and report status of work.
• Proficiency with Microsoft applications, including Word, PowerPoint, and Excel and the basic Windows operating system.

WORKING CONDITIONS:
• Our facilities are a heated, air-conditioned and humidity controlled production floor and /or clean room environment.
• Our buildings are modern, with employee accessible WiFi, dedicated break, quiet, and collaborative spaces, and an on-campus cafeteria.

EDUCATION/EXPERIENCE:
• Must have 2+ years relevant experience in a similar role
• High School Degree (minimum)
• Experience in a regulated industry preferred (e.g. FDA, ISO)