1. Support the development, implementation, and oversight of an effective Quality Management System that operates in compliance with corporate quality polices and procedures, and relevant regulatory requirements and industry guidance;

2. Handle Nonconfirmity and organize regular review;

3. Lead and/or support the oversight of product realization and commercial manufacturing activities, such as product/specification development, tech transfer, process capability and materials management.

4. Support the testing, review, and disposition process for production batches and incoming raw materials, including management of deviations and nonconforming product.

5. Customer support; including:

- Support customer audits, including response and corrective action tracking

- Partner in the resolution of quality issues and customer requests by initiating effective interdepartmental communication.

6. Other tasks assigned by supervisor/manager

1. Bachelor’s Degree – Life Sciences or Engineering.

2. Minimum five(5) years of experience in a regulated industry, such as life sciences, food and beverage, automotive, semiconductor or aerospace with preferred emphasis in life sciences (e.g. pharma, biopharm, or medical device).

3. Minimum one (1) year in a Quality role (Quality Specialist, inspector, technician)) within a manufacturing environment. Understanding of 6 sigma concepts desirable.

4. Good analytical / problem solving, project management, interpersonal and organizational skills required.

5. Have good verbal and written communications skills to interact with internal and external personnel on plant processes, projects, and investigations.

6. Must work well in a team environment, possess an ability to adapt to change in the environment, and have proven ability to exert influence in a directive and positive manner.

7. Proficient computer skills required including Microsoft Word, Excel, PPT