Quality Assurance Associate IV

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 Associate IV  Department Name: Quality Assurance   Location:Santa Clara, CA  Job ID Number: 00332  Position Summary: Responsible for assuring the quality of licensed and development-stage products manufactured at MedImmune and contractors. The QA Associate IV assists a number of functional areas including Process and Clinical Development, Manufacturing, Facilities, and other Quality departments. Implements quality policies, manages quality systems, and assists in facilitating regulatory compliance inspections. The QA Associate IV provides leadership, coaching and guidance to peers in the Quality Assurance department, and customer organizations. In certain circumstances may serve as a designated approver for the Manager and/or the Associate Director of Quality Assurance. Major Duties and Responsibilities: • Maintains quality assurance systems in a state of compliance with current good manufacturing practice regulations. Administers the change control, deviation, and corrective action systems for assigned products and quality systems. Maintains database; generates standard and ad hoc reports; evaluates trends. • Works closely with Materials Management, Quality Control, and Production departments to assure a continuous supply of product to our customers. Alternately, coordinates product release timelines with Project Managers, Manufacturing and Clinical Development to meet clinical trial start dates. • Supports the evaluation and disposition of labeling, raw materials, intermediates and finished products through timely compliance evaluation of batch records, laboratory results, and other cGMP documents. Prepares lot release packets in standardized format for upper management review and disposition. • Coordinates investigation teams to assess the impact of minor and major non-conformances that may occur during manufacture, testing, or distribution of products, or during the administration of quality systems. Identifies root causes, recommends and implements corrective actions to prevent recurrence. . • Interprets trends in regulatory guidance, and compliance enforcement actions. • Performs trend analysis to monitor process and facility performance. Employs metrics to track the performance of operations and quality systems. • Reviews and approves equipment qualification protocols and summary reports. Reviews development reports. • Supports QA Compliance in completion of product annual reviews. • Performs in-plant inspections of active production areas to resolve problems early and to assure compliance with SOP and regulatory requirements. • Approves areas and equipment for use following re-qualification. Performs area changeover inspections between manufacturing campaigns and authorizes the use of the area for the next product campaign. • Performs additional duties as required. Requirements / Qualifications: Education: Requires a BS degree in the life sciences or engineering, or equivalent. Experience: At least 6 years in GXP-regulated industry, with at least two years in quality assurance, quality control, or validation.  If you are interested in this position, apply online at 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 Associate IV Company:  MedImmune Inc. Location:  Santa Clara, CA 95054 Status:  Full Time, Employee Job Category:  Biotech/R&D/Science Company: MedImmune Inc.