Regulatory Affairs Specialist II

Associate Technician Production Operations (O2) Description/Comment: Our manufacturing company is seeking a team member to join our Packaging team. In this role you will load diagnostic panels, monitor the drying process, unload diagnostic panels, and package diagnostic panels and 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 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 drying and packaging of panels. Apply basic analytical skills or scientific methods to perform daily tasks. Perform the set-up, testing and troubleshooting of diagnostic panels. 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. EDUCATION/EXPERIENCE: High School Degree or Equivalent. Experience in a regulated industry preferred (e.g. FDA, ISO). #J-18808-Ljbffr TechDigital Group