GLP QA Associate III/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: GLP QA Associate III/IV Department Name: GLP R & D Quality Assurance Location: Gaithersburg, MD Req Number: 00441Position Summary: Major Duties and Responsibilities (including supervising others): • Assuring Good Laboratory Practice (GLP) nonclinical study compliance with MedImmune’s standard operating procedures and the GLP regulations (FDA, MHLW and OECD); • Performing in-process inspections of study phases and analytical methods, audits of study data and final reports, and audits of internal facilities; • Performing initial or periodic vendor audits and/or assessments including but not limited to, policies, procedures, gaps from GLP regulations (FDA, MHLW and OECD), including in-process inspections during MedImmune contracted studies. • Summarizing audit findings in written report format, perform trend analysis of findings; • Establishing and maintaining QA files and records; • Writing and revising controlled documents (e.g. SOPs) in support of job responsibilities; performing QA review and approval of controlled documentation for supported groups; • Working with contract auditors to assure that MedImmune standards in the conduct and reporting are maintained in contracted external audits; • Participating in the development, implementation and maintenance of GLP compliance systems and training programs where applicable; • Working with other MedImmune personnel in other departments, particularly Translational Sciences and Vaccines Research; external relationships include interactions with contract research organizations, and outside testing laboratories; • Developing and maintaining effective working relationships within and across departments in relation to projects. Requirements/Qualifications:Job RequirementsQualities: • Exhibits professional behavior and possesses the appropriate level of education, knowledge, experience and training to properly evaluate the area of concern; • Ability to deal with, and react to, diverse populations openly and honestly; • Has the skills necessary for clear and effective communication; • Has the knowledge of ways to resolve problems within the audit team and also between the team and those being audited; • Detail oriented and investigative nature; • Possesses self control to remain neutral and objective at all times; • Should not have conflicts of interest with the audited organization; • Able to always maintain confidentiality of the audit; • Can determine the duration, breath and depth of the audit without input from the auditee; • Be able to provide sufficient time to allow for a full response to verbal queries and listen carefully to answers; • Be able to assess and consider the auditee’s workplace environment (quality of the establishment) as a whole and not just the words of the personnel being questioned; • Be able to base judgments solely on documented evidence and record findings that support the observations; • Should not draw broad conclusions in place of specific factual summaries; • Be able to communicate and clarify all audit requirements, and promptly report the audit results; • Be able to verify the effectiveness of the corrective actions taken as a result of the previous audit; • Excellent technical report writing skills; • Strong communication, interpersonal and problem solving skills; • Intermediate to advanced knowledge of Microsoft Office Suite programs (MS Word, Excel, PowerPoint) • Embraces MedImmune’s values in spirit and actions. Job Complexity • Simultaneously works on problems of diverse scope, analyzes the situation, consults with supervisor and colleagues when necessary, and determines the best path forward; • Exercises good judgment within generally defined practices and policies in selecting method. Supervision • Minimal supervision; • Must be able to act independently. Experience & Educational Background • RQAP-GLP Certification strongly preferred. • Five years (QA Specialist III) to 10+ (QA IV) auditing experience in all aspects of GLP studies. • A strong understanding of GLPs and an ability to apply them to nonclinical research and/or related processes is required. • Position requires domestic and international travel (approximately 25-30% ) 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: GLP QA Associate III/IV Company:  MedImmune Inc. Location:  Gaithersburg, MD 20878 Status:  Full Time, Employee Job Category:  Other Company: MedImmune Inc.