Quality Assurance Specialist III

Position Summary:

The Quality Assurance Specialist III will provide on-site advanced-level, hands-on support from a regulated systems perspective in a GxP laboratory services and kitting production environment. Activities include but are not limited to, product label control, internal auditing, and quality inspection & release of raw materials, in-process materials, finished products, and critical components. In addition, this position is responsible for managing the document and record control system. Extended work hours may be necessary in order to meet business demands.

Essential functions of the job include but are not limited to:

Quality Function:

• Assist in maintaining established company-wide GxP quality systems, actively managing assigned activities (including logging and tracking of events and outcomes), and working with end-users on thorough documentation of quality system events (to include closure or resolution in a timely manner):

*Non-Conformances

*Customer Complaints

*Planned Deviations

*Change Management

*Co