Manufacturing Supervisor

OraSure Technologies Inc. (OTI) empowers the global community to improve health and wellness by providing access to accurate, essential information. Our ability to positively affect change is powered by the innovative tools and diagnostics we deliver to the market. 

Together with its wholly owned subsidiaries, OTI provides its customers with end-to-end solutions.

It's first-to-market, innovative products include rapid tests for the detection of antibodies to HIV and Hepatitis C (HCV) on the OraQuick platform; sample self-collection and stabilization products for molecular applications; and oral fluid laboratory tests for detecting various drugs of abuse.  

Overview 

Here at the OTI our innovative sampling tools and diagnostics unlock access to accurate, essential information that advances global health and well-being. Our products include molecular sampling kits for the genome and microbiome, and rapid diagnostics for infectious disease.  

Responsible for the overall direction, training, and evaluation of the assigned production area(s) to ensure the timely and accurate assembly of product.

Carries out supervisory responsibilities in accordance with Company policies. Responsibilities include interviewing, training, planning, assigning, and directing work, evaluating performance, and addressing employee relations.

• Train, mentor, coach, and develop Manufacturing Technicians and Group Leader(s). Promote an environment and culture of continuous improvement.
• Lead and inspire staff to meet production, quality, and safety objectives.
• Identify, escalate, and report quality and/or safety concerns to appropriate area management. 
• Ensure a safe work environment Is provided by regular walkthroughs and audits. Ensure employees follow safety procedures and work safely.
• Schedule and plan departmental workflow, personnel, equipment, and other resources in order to meet production commitments.
• Ensure all Manufacturing Associates receive adequate training and support to perform their jobs with excellence.
• Conduct performance appraisals, promotions, reward/recognition, and disciplinary actions where appropriate for direct reports.
• Collaborate with cross-functional teams, including quality assurance, engineering, and supply chain, to implement process improvements, optimize efficiency, and resolve manufacturing issues.
• Coordinate with Maintenance, Engineering, and Research & Development departments to assist with product and machine development.
• Coordinate with the Production Planner(s) to assist with scheduling and monitoring of inventoried and non-inventoried supplies. Ensure accuracy of Bill of Materials (BOMs) and Recipes.
• Coordinate with the Warehouse staff to ensure timely movement of materials to and from the production area.
• Deploy Lean Manufacturing techniques to increase/sustain productivity, throughput, safety, and customer satisfaction.
• Utilize statistical process control (SPC) to monitor production processes, reduce variability, and improve product quality. Perform or facilitate investigations into statistically significant events.
• Perform, document, and present investigations for non-conforming product and/or processes. 
• Identify root-cause of non-conformances and recommend corrective and preventative actions to eliminate reoccurrence. Perform verification of completed corrective and preventative actions.
• Comply with all applicable regulatory guidelines, such as FDA regulations, ISO standards, and Good Manufacturing Practices (GMP). Assure GMP compliance through use of appropriate physical, written and work practice controls. .

• Three (3) to five (5) years' experience in an FDA regulated production environment.
• Bachelor's degree in science, engineering, or related field with two to five years of working experience in a production environment preferred. A combination of relevant work experience and formal education may also be considered
• Experience in an ISO/cGMP environment.
• Excellent organizational skills and detail oriented. Ability to manage multiple priorities is necessary. Project management skills are desirable.
• Ability to communicate effectively both orally and in writing (English) with management, staff, and other departments.
• Ability to read and interpret written procedures and specifications.
• Windows-based computer skills, to include Microsoft Word, Excel, Project, and Visio.
• Working knowledge of statistical methods and software (i.e. Minitab)
• Experience in using material management and production control systems, preferably SAP.
• Ability to apply principles of logical thinking to a wide range of practical problems.
• Mechanical aptitude for general maintenance of equipment desired.