Manufacturing Technician Lead

ABOUT GENALYTE 

At Genalyte, we're revolutionizing diagnostic testing to empower a healthier future. We believe that timely and accurate health insights shouldn't be a luxury, but a necessity. We are driven by a vision where advanced diagnostic capabilities are accessible, efficient, and seamlessly integrated into healthcare. Genalyte is more than just a laboratory; we are advocates for health empowerment, dedicated to providing insights that can transform lives and communities.

WHY WORK FOR US 

We believe in investing in our employees' well-being and success. As a valued member of our team, you'll have access to a comprehensive benefits package, including competitive salary, health, dental, and vision insurance, and generous paid time off. Additionally, we offer stock ownership and equity participation, providing you with the opportunity to directly share in the success and growth of the company. Join us in shaping the future of healthcare while building a rewarding career.

POSITION SUMMARY
Under minimal supervision, this position is responsible for leading and assisting the consumables manufacturing department  and team members in carrying out complex manufacturing, Quality Control processes, and tasks involving a variety of laboratory methods, operation of simple to complex equipment, and various manual manufacturing processes. This position also assists the area Supervisor or Manager with assigning daily tasks and monitoring progress in order to meet quality standards and production goals.  The lead role is expected to consistently demonstrate the behavior, work ethic, and standards they expect from others on their team.

ESSENTIAL FUNCTIONS & RESPONSIBILITIES:

These may include but are not limited to: 

• Adheres to all safety guidelines and practices and is a leading safety practices advocate ensuring all production employees comply with OSHA and company safety standards
• Adheres to all company Quality Standards and is a leading advocate in ensuring all production personnel follow the organization’s quality standards, processes, and procedures. Observes and routinely operates to QSR, GMP, GLP, and ISO regulations
• Coordinates production activities and assigns tasks to technicians based on scheduled daily priorities and utilizing provided tools
• Monitor and track daily employee attendance, punctuality, and breaks, escalating any issues or discrepancies to manager
• Assists personnel in troubleshooting production line related issues and escalates to appropriate support groups within the organization to minimize production downtime
• Familiar with all current manufacturing processes, procedures and policies in the Consumables Manufacturing department
• Assist in recommending, drafting, and revising manufacturing documentation, including SOP's, DHR's, specifications, and testing protocols
• Is able to perform basic to complex manufacturing tasks to include operating equipment
• Collaborates with Manager to establish department objectives, milestones, and timelines for completion
• Coordinates and/or facilitates team training and mentors junior team members as appropriate and/or as directed by the manager
• Participates in new product/process transfers. Ensure required documentation is complete. Collaborates with R&D, Engineering, Quality and any other departments as appropriate to establish transfer timelines consistent with milestone due dates
• Maintains a strong awareness of quality consequences and potential device defects related to their responsibilities

ADDITIONAL FUNCTIONS & RESPONSIBILITIES: 

• Exercises flexibility in supporting cross-functional activities and regularly interacts with all departments, including but not limited to, representatives from Engineering, Quality, Production Planning, Purchasing, Finance/Accounting and R&D
• Participates in periodic reviews of component labor routings, material requirements, BOM's and cycle counts. Ensures information is accurate and up to date
• Establishes and maintains lines of communication to ensure the timely and accurate flow of information and coordinates tasks with  staff members in a cohesive and effective manner

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:

• AA/AS degree with 4-6 yrs of relevant experience with at least 2 years in a Lead role
• BA/BS degree with 2-4 yrs of relevant experience. Degree in Chemistry or Biological Sciences is a plus
• Demonstrated skills in executing manufacturing operations with minimal guidance in an accurate, effective manner
• Knowledgeable of federal and other regulations, e.g. QSR’s, ISO, ISO 13485, CMDR
• Demonstrate problem-solving and troubleshooting skills
• Strong verbal and written communication skills
• Organized and detail oriented
• Knowledge and ability to use MS Office, inventory control and other manufacturing systems
• Ability to work in a team environment