JOB PURPOSE:    
Designs, engineers, and implements quality systems to ensure regulatory compliance and quality improvements. This includes designing, planning, and executing validation activities for Over the Counter (O.T.C.) Drugs in accordance with Food & Drug Administration (FDA) regulatory guidelines.  Supports quality engineering initiatives (i.e., conducting process capability studies and process improvement investigations), to improve quality, capacity, and efficiency while reducing costs.

Independently plan, perform and/or coordinate validation projects to ensure timely completion. Draft and coordinate execution of validation documents for Equipment Qualification (IQOQPQ), Process Validation and Cleaning Validation/Verification. Draft/or provide technical guidance for SOPs/Work Instructions and other master documents. Remain current with industry and regulatory agency trends. Provide technical leadership for deviation investigations. Analyze data and provide recommendations for improvements in manufacturing process, and equipment. Prepare protocols and other technical documents, and participate in the interpretation of data, collaborating with other departments. Other responsibilities as directed.

ESSENTIAL DUTIES AND RESPONSIBILITIES:     
1. Interfaces with personnel in Quality Assurance Laboratories (Microbiology (QCM) and Chemistry (QCA)), Process Development, Product Intergrity, Engineering, Contract Services, Regulatory Affairs, Package Engineering, Scheduling, Packaging, Processing and Central Weigh to design, plan, write protocols, execute, document results, and gain the required approvals for all validation activities.  Validation activities include, but are not limited to product processing, product packaging, and utilities.

2. Collaborates with Site/Corporate Engineering or Process Development and directs all Qualification activities for newly purchased equipment.

3. Develops validation master plan, qualification, and validation schedule.  Ensures that validation/qualification projects and timelines are structured in accordance with FDA regulatory guidelines.  Informs Quality Assurance management of status of validation projects on a regular basis.

4. Plans and organizes all validation execution activities, including scheduling validation runs, collecting and analyzing data, and documenting results.  Coordinates with management, the allocation of all resources towards validation efforts.

5. Compiles validation and other technical work in report format for future use, including building a technology base of pertinent continuous quality improvement related issues and solutions.  Implements re-validation process improvements as required.

6. Interfaces with personnel in Quality Assurance, Packaging, Processing, etc. to identify potential areas for product quality and process improvement.

7. Identifies the source of variation in all manufacturing processes and seeks to reduce unnecessary variation, through the use of various statistical and quality improvement tools (i.e. experimental design, statistical process control).