Lindsay Smith

Ø Manages and leads all departmental employees including four supervisors, aseptic engineer, two non-conformance technicians, three trainers, and eighty-six non-exempt employees working in a 24/7 manufacturing plant.

Ø Provides direction and guidance for manufacturing projects involved the aseptic process.

Ø Assure all non-conformance investigations are thorough and accurately assess the situation as well as provide effective corrective actions when required.

Ø Tracks critical department metrics including spending, line performance, safety, and quality metrics.

Ø Champions projects to reduce scrap, improve efficiency, and improve product quality.

Ø Set and manage annual departmental budget for labor and spend.

Ø Supervises the MQA Product Release and MQA Line Inspection groups which includes nineteen non-exempt employees.

Ø Tracks and manages performance evaluations of department staff.

Ø Monitors the departmental spending and budget.

Ø Developed and maintains department SQDCI boards.

Ø Provides routine analysis of performance indicators and presents the information to management.

Ø Ensures solutions and contract manufacturing lots that do not conform are investigated within the pre-established turn-around timeframe.

Ø Reduced late releases due to MQA related events by approximately 60% from 2017 to 2020.

Ø Played a pivotal role in the implementation of a new retain inventory management process by leveraging existing capabilities of Lx.

Ø Leads and supports investigations and corrective action plans using root cause analysis tools.

Ø Reviews validation protocols for adherence to regulatory and compliance standards.

Ø Ensures new products and processes are integrated into the existing quality systems.

Ø Presents failure rate analysis to senior management on a monthly and quarterly basis.

Ø Work with manufacturing and engineering to develop continual improvement projects for products and processes.

Ø Develops and maintains PFMEA for processes within area of expertise.

Ø Performs process audits to support the internal audit program.

Ø Managed quality change control requests.

Ø Provided technical and production assistance to all chemistry laboratory personnel to coordinate testing of raw materials, in-process testing, and finished product samples in a timely manner to meet KOMs.

Ø Led department specific continual improvement projects.

Ø Assisted in the transfer of new methods to the facility.

Ø Participated as the department representative on a new product development team.

Ø Authored changes and updates to test procedures, directives, and standard operating procedures.

Assigned Lab Projects and Testing