This is a 2nd Shift Position. Working hours are Monday through Friday, 2:00 PM to 10:30 PM. KEY RESPONSIBILITIES/ESSENTIAL FUNCTIONS: Assist Operational Quality Manager in coordinating and executing objectives throughout the company in cooperation with other Lead Quality Inspectors to maximize product quality and operating system efficiency/effectiveness to minimize costs. Direct and coordinate the activities of Quality Inspectors engaged in the evaluation of goods. Perform all the functional duties and responsibilities of the Quality Inspector. Plan and establish work schedules for the QC inspectors, assignments, and production sequences to meet production goals. Read and analyze charts, work orders and other records and reports, in order to determine resource requirements. Review data and documentation for accuracy and correctness and ensure processing is performed within established time expectations. Analyze statistical data to determine adequacy of present standards and establish quality plans. This includes analysis of current inspection methods and sample plans. Assist in the oversight of nonconforming product during the production stage, managing daily material disposition. Responsible for batch release, CoC/ CoA creation Ensure all in-process and start-up requirements are met with respect to LRP and usage decision, consult with Operational Quality Manager for discrepancies. Responsible for the LRP closure and compliance to company cGMP. Prepare necessary quality and safety reports. Consult with management and staff to address work related issues/complaints with support of Operational Quality Manager and Quality Engineer. Observe work performed by Quality Inspectors to ensure staff conforms to quality system standards. Participate in investigations regarding customer complaints. Utilize problem solving techniques to reduce internal and external failures. Provide training as needed for the QC department. Executes specific responsibilities as defined within the company quality system. Supports and maintains all policies of the company including but not limited to applicable FDA regulatory and ISO requirements, Health and Safety Requirements and Continuous Improvement initiatives. Coach and mentor employees to ensure they maintain or exceed company and/or department performance expectations. Provide feedback and performance information to Quality Managers to assist in their preparation of Performance Reviews. Other duties as assigned. POSITION REQUIREMENTS: Associates Degree or minimum of 3 years related work experience with one of those years in a leadership role. Must be able to perform all quality inspector functional job responsibilities. Good working knowledge of raw materials, production processes, costs, and other techniques to maximize effectiveness. · Knowledge of inspection tools, use, and maintenance of those tools required. · Must be self-directed and demonstrate skills in planning and organizing. · Able to lift up to 35 lbs. · Ability to sit, stand, walk 80% of shift required. PREFERRED KNOWLEDGE/SKILLS: Excellent oral and written communication skills. Ability to apply basic mathematical concepts. General knowledge of PC applications such as Microsoft Word, Excel, and Database software. WORK ENVIRONMENT: Works in a clean room manufacturing environment that may include moderate noise levels and required appropriate cleanroom apparel. Ability to travel between office and production departments as well as company buildings required.