Quality Specialist III

Organization: 
MedImmune
Job Location: 
Frederick, MD
Job Description: 

Responsible for assuring the quality of products manufactured at the facility. Performs on the floor inspections of the production areas to resolve issues early and to ensure compliance with SOP and regulatory requirements. Supports functional areas including manufacturing, facilities, and other Quality departments. Implements quality policies for process improvements, manages quality systems, and assists in facilitating regulatory compliance inspections. Utilizes Quality Systems in compliance with current good manufacturing practices. Maintains database, generates routine reports. Supports the evaluation and lot disposition of intermediates and finished products through timely review of batch records, laboratory results and other GMP documents. Investigates and assesses the impact of minor and major deviations that may occur during manufacture, testing or distribution of products. Identifies root causes, recommends and implements corrective actions to prevent recurrences. Employs metrics to track performance of operations and quality systems. Performs trend analysis to monitor process and facility performance. Reviews, assesses and approves change control and NC and corrective action. Interprets complex data and ensures compliance with specifications. Understands application of validated systems and functionality of their use in Quality Systems. Works under only general direction. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy, in meeting objectives. Contributes to the completion of specific programs and projects. Primarily internal company contacts. Frequent inter-organizational and outside customer contacts. Represents the organization in providing solutions to difficult technical issues associated with specific projects.

Requirements:
Position:
5-7 yrs of QA experience.
Prior night shift experience is desirable.

Education:
Bachelors in Sciences