Work Schedule First Shift (Days) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degrees, Fluctuating Temps hot/cold, No eye contacts allowed; prescriptive glasses will be provided, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Will work with hazardous/toxic materials Job Description Lead Operator - Assembly Department Job Summary: The Lead operator will coordinate manufacturing operations for the Assembly Department. This pivotal role supports and enhances the daily production efforts, ensuring efficient operation and compliance with all regulatory standards. You will act as a supervisor's assistant, coordinating the floor, scheduling, delegating, trouble shooting, resolving issues, and leading a team of 8-15 operators. Job Responsibilities: * Production Oversight: Lead daily operations to ensure timely completion of production schedules while maintaining high standards of quality and efficiency. Use our inventory management system (E1) to perform labor hour issuing and completion of WO. * Team Leadership: Lead and motivate a team of operators, promoting a safe and positive work environment to achieve daily production goals. Responsible for shift-to-shift communications, facilitating seamless transitions. * Compliance and Quality Control: Monitor adherence to ISO, GMP, FDA, and Class 7 requirements. Ensure all production activities follow company policies and standard operating procedures (SOPs). * Documentation and Reporting: Complete reviews of production documents, close work orders, and handle documentation related to problem reports, CAPA, and change control. * Process Improvement: Lead departmental projects aimed at process improvement and cost savings. Apply lean manufacturing principles to enhance operational efficiency. * Training and Development: Ensure that all team members receive timely and effective training. Be responsible for the development and updating of training materials as necessary. * Problem Resolution: Initiate problem reports for deviations and non-conforming materials. Own processes within the Quality System, conducting root cause investigations and implementing corrective actions. Nature and Scope: The Lead Operator is responsible for one or more work centers, focusing on safety, quality, and compliance daily. . Attention to detail and accuracy is required in performing all functions of this position as errors in work could cause customers to receive a non-conforming product. This role requires effective communication and leadership skills to maintain a skilled manufacturing team and ensure the production of high-quality products. Builds and cultivates a culture centered around Safety, Quality, and Teamwork to ensure adherence to all safety and quality applicable regulations (i.e. OSHA, ISO13485, etc.). Continually review processes and results, anticipate problems, and troubleshoot processes and equipment with the assistance of other support groups. Qualifications: Education: Associate degree required; bachelor's degree preferred. Experience: Minimum of 1-3 years related experience in a supervisory or lead role, preferably in a manufacturing environment. Skills: * Strong leadership and interpersonal skills. * Proficiency in Microsoft Office Suite. * Demonstrated problem-solving skills, PPI & lean manufacturing experience. * Excellent time management and the ability to work in a fast-paced environment with changing priorities. * Must be able to start work on-time daily and maintain strong attendance performance. * Must be flexible, able to handle multiple tasks simultaneously, and meet tight deadlines. * Follow policies and procedures, instructions, and to meet project timelines consistently and independently. * Demonstrated ability to apply problem solving methodology to understand root cause and implement solutions. * Serves as an Assembly SME (Subject Matter Expert) for identified manufacturing processes and Equipment's. Physical Requirements / Work Environment * Ability to regularly lift and/or move up to 25 to 50 pounds. * Ability to wear personal protective equipment when required. * Able to properly handle and process materials that are in temperature sensitive conditions in accordance with established standard operating procedures to ensure customers receive a product that meets or exceeds quality specifications (Ambient, Cold Room (2-8), Freezer (-20), and Ultra Cold (-80). At Thermo Fisher Scientific, each one of our 50,000 extraordinary minds has a unique story to tell. Join us and add to our singular mission-enabling our customers to make the world healthier, cleaner, and safer. Apply today! http://jobs.thermofisher.com Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other employment benefits and privileges Please contact us to request accommodation.