Heather Zach Email and Phone Number

- Directs multiple departments, including the Raw Materials QC group, Supplier Quality group, and the Immuno diagnostics QC group.- Developed the Supplier Quality program.- Managing the raw materials validations.- Lead Auditor for the internal auditing team.- Perform Supplier Quality audits as needed.

• Directs and coordinates daily activities of all ELISA and Lateral Flow Quality Control departments.• Developed a complete training program and assessments for each level of departmental employees• Develops and maintains planning and scheduling to assure quality product availability to meet customer requirements• Works with R&D in early stages of product development to insure quality specifications and designs are incorporated early in the process• Works with Manufacturing on alternate processes to improve product quality, reduce lead-times and improve costs• Develops, executes and maintain Standard Operating Procedures to meet current cGMP/ISO requirements• Eliminate non value added processes and improve testing efficiencies• Assist in troubleshooting quality problems with various other parts of the organization• Supervise direct reports and performs annual performance assessments• Insures all staff are current in training requirements• Develops and executes annual departmental budgets, including staffing, capital and operating expenses • Prepare and present reports and analysis of data as required• Administers corporate policies and insures adherence to by staff through direct reporting managers

• Oversee operation of Food Safety Diagnostics and AccuPoint QC labs.• Manage activities and training of up to 8 departmental employees.• Revise/develop QC documentation for all QC processes.• Approve and reject product coming from manufacturing for multiple product lines.• Develop and maintain an effective stability program with the goal of extending product shelf-life.• Perform and/or direct routine microbiological and immunological testing to determine compliance with specified performance standards.• Participate on technical review or new product development teams and develop new QC procedures for transferred products.• Manage and maintain a yearly balance for the department• Act as the backup for the QC Manager and Director in their absence.

• Assist in the formulation of reagents and preparation of some components used in the assembly of lateral flow devices according to Standard Operating Procedures. • Formulate chemical reagents from stock.• Conduct chemical reactions for development of reagents.• Dispense prepared solutions onto membranes.• Participate in validation and verification procedures pertinent to manufacturing of reagent.• Participate in product/process improvement of current products.• Manage a manufacturing schedule for production based on product forecasts.

• Perform routine chemical and immunochemical assays on manufactured diagnostic products to determine compliance with specified performance standards. • Adhere to GLP/ISO guidelines in daily activities.• Perform incoming inventory inspections.• Assist in the development of new QC procedures.• Perform equipment qualification.

• Perform shelf maintains on medication inventory weekly• Order specialty items for customers• Consulted with insurance companies about prescription processes• Processed prescription in timely manner• Consulted with patients about medication• Assist pharmacist in special projects