Job Description
Job Summary:
- Our company is seeking a team member to join our Large Scale Reagent Manufacturing team.
- In this role you will formulate and test chemical and biological reagent products of varied complexity according to operational plans and customer demand.
- We’re looking for associates who 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, comprehend and follow established work instructions and procedures with emphasis on quality.
- Execute the daily production plan to due date conformance and quality standards.
- Train to Standard Operating Procedures (SOPs).
- Follow engineering drawings, work order information, SOPs, and other written and verbal specifications in the manufacturing process while maintaining FDA requirements.
- Independently execute work regarding formulating and testing.
- 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.
- Read, write and speak fluent English.
- Proficiency with Microsoft applications, including Word, PowerPoint, and Excel and the basic Windows operating system.