QC Analyst I/II-Stability

Essential Job Functions: Assist in managing the global product stability program for drug substances and drug products• Coordinate contract testing for stability program• Assist in review, revise, and implement stability protocols for commercial drug products• Assist in trending data generated from stability studies• Assist in generation of reports of stability studies for Regulatory Affairs and other external agencies• Assist in maintaining timely schedule for the submission of stability section for the annual report• Schedule, prioritize and monitor all marked product stability testing• Interact and coordinate with Regulatory, QA, and other departments for protocol approval and amendments• Provide results and summaries of stability studies to internal and external customers• Coordinate the deviation and OOS investigation for commercial stability lots• Assist in the implementation of new technology for existing stability studies• Coordinate the commercial product complaints investigation activitiesPosition Summary: Candidate will have the ability to successfully assist and coordinate the product stability program at MedImmune. General knowledge of cGMP, ICH requirements, stability and validation experience is preferred.Typical Education:Bachelors: Pharmacy, Chemistry, BiochemistryTypical Experience:0-3 years of analytical testing experience in pharmaceutical or biopharmaceutical industryReasoning Ability:Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions. Ability to deal with problems involving a few concrete variables in standardized situations.Computer Skills:Outlook, InSight, LIMS, Internet Explorer, MS Powerpoint, MS Project, MS Excel, MS WordCLICK HERE TO APPLY 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: QC Analyst I/II-Stability Location:  US-MD-Frederick - NON SALES Status:  Full Time, Employee Job Category:  Sales/Retail/Business Development