QC Analyst III

MedImmune, LLC Location: Frederick, Maryland-Montgomery County 21703 Posted on: 6:46 PM, Thursday, August 21, 2008 Position type: Full time Job Code: 00804 Required education: Bachelor's Degree Area(s) of expertise desired: Laboratory, Quality Control Description 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: QC Analyst III Location: Frederick, MD Req Number: 00804 Essential Job Functions: Perform immunoassay, plasma, DNA analysis, and other Quality Control procedures. Prepare SOP’s and train the appropriate personnel. Assist in technology transfer. Prepare and execute installation, operation, and performance qualifications. Evaluate, implement, and validate new procedures. Prepare validation protocols, perform validation experiments, and prepare validation reports. Conform to all GLP/GMP requirements. Additional Job Functions: • Perform immunoassay, plasma, and DNA for in-process and final product testing to support the release of licensed products and Phase III products. • Maintain instrumentation and other laboratory instrumentation according to maintenance schedules and GMP requirements. • Train other analysts in Quality Control procedures. • Calibrates and maintains equipment according to standard operating procedures. • Identifies and troubleshoots equipment problems. • Reviews data obtained for compliance to specifications and reports abnormalities. • Prepares validation protocols, executes experiments, and prepares validation reports. • Responsible for writing new SOP’s or revising existing documentation. • Prepares documentation for presentation to Regulatory Agencies. • Applies critical thought to solving problems of complex scope. • Works on technically complex problems where analysis of situations or data requires an in-depth evaluation of intangible factors. • Acts independently to determine methods and procedures on new assignments. • May provide guidance for lower level personnel. • Applies knowledge of good manufacturing practices and good laboratory practices on a daily basis. • Adheres to Company safety procedures and guidelines on a daily basis. Requirements . Typical Education: Bachelors: Scientific / Biotech / Pharmaceutical field of study Typical Experience: 5-7 years experience Computer Skills: LIMS, EDMS,CLSD,TestTrack, Excel, Softmax, Word If you are interested in this position, apply online at www.medimmune.appone.com and search for Req 00804. MedImmune, LLC. 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.