Quality Assurance Specialist II

I have a passion for excellence. At MedImmune, we do too.MedImmune is a recognized leader in the biotechnology industry, we use the latest advances in science, technology and medicine to develop innovative products that improve the quality of human health. We strive to create a work environment that is professionally and personally rewarding, characterized by respect, integrity and opportunities for growth.  Hundreds of thousands of patients have benefited from our products, which are designed to treat or prevent infectious diseases, cancer and inflammatory diseases. Our extensive research and development efforts are focused on these same areas.  Both individual contributions and team successes are critical on the path to scientific and medical breakthroughs. Position Title:Quality Assurance Specialist IIDepartment Name:Clinical QualityLocation:GaithersburgJob ID Number:00112 Job DescriptionPosition Summary: The candidate is responsible for assuring the quality of cell culture derived influenza vaccine manufactured at the MedImmune facilities in Maryland, primarily in the Human Genome Sciences site. The QA On-the-Floor (OTF) Specialist is expected to be present and available during critical production activities to conduct real-time reviews, to ensure adherence to MedImmune’s approved procedures, and to maintain compliance to cGMP. The QA-OTF Specialist will support a number of functional areas including Manufacturing Sciences, Facilities and other Quality departments. Major Duties and Responsibilities (including supervising others): 1. Utilizes quality assurance system in compliance with current good manufacturing practices and regulations. 2. Performs a Process Area Clearance according to MedImmune’s approved procedures prior to beginning of critical operations. 3. Monitors critical production activities to assist Manufacturing Sciences personnel in detecting and resolving compliance issues, and advising on documentation or entry errors. 4. Performs real-time review of batch records during production to resolve problems early and to ensure compliance with our current procedures and regulatory requirements. 5. Manages workflows to assure timely release of clinical product. 6. Investigates and assesses the impact of minor and major deviations that may occur during manufacturing of products. 7. Assists in identifying root causes for deviations, recommends and implements corrective actions to prevent recurrence. 8. Reviews change controls of SOPs, MPRs/SPRs and other GMP documentations. 9. Employs metrics to track the performance of operations and quality systems.  Job RequirementsEducation: Bachelors in a scientific discipline/Biotechnology. Experience: 3-5 years technical experience (preferably in a GMP manufacturing environment). Special Skills/Abilities: Experience with certain electronic quality systems such as Trackwise, LIMS and EDMS is desirable. Experience in monitoring production in a GMP/GLP setting is a strong asset. Job Complexity: Medium. Supervision: Receives general to detailed instructions on routine work and new assignments.(supervision required, level of independence) Job Complexity: Medium. Supervision: Receives general to detailed instructions on routine work and new assignments. (supervision required, level of independence)  If you are interested in this position, please apply at http://www.medimmune.appone.com/  MedImmune, Inc. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law. MedImmune, Inc. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law. Job Title: Quality Assurance Specialist II Company:  MedImmune Inc. Location:  Gaithersburg, MD 20878 Status:  Full Time, Employee Job Category:  Other Company: MedImmune Inc.