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Associate I, Quality Control (Clinical Biochem - Two Opportunities) Durham United States,  

Posted on : 25 April 2017

Project Description

External Posting TitleAssociate I, Quality Control (Clinical Biochem - Two Opportunities) Job Description***Please note that this posting represents two open opportunities***The QC Associate I is responsible for supporting key functional, tactical, and operational aspects of the QC Biochemistry group at Biogen. The incumbent will perform release and stability testing and all associated activities associated with this testing. Responsibilities include, but are not limited to, training, testing support for release and stability, support for transfer qualification/validation activities as appropriate, robust and compliant cGMP documentation practices. A fundamental understanding of the Biogen Quality Systems and able to apply it in their daily support functions. The incumbent will be responsible for adherence to all GMP requirements, a basic understanding of FDA/EMA regulations, and effective interactions/communication with Quality management, personal development, and support of investigations. The incumbent should be able to work effectively within the group.Principle Accountabilities: • Performs release and stability testing• Provides timely review/corrections for data and documentation generated for or by QC • Participates in the execution of method transfer, method development, method qualification, analytical improvement projects, control qualification, and validation of analytical methods in collaboration with teams as appropriate• Supports maintenance of effective laboratory systems to ensure integrity of all laboratory results*LI-CTL2 LocationResearch Triangle Park, NC, US Job CategoryQuality Requisition Number30215BR QualificationsThe QC Associate I will possess demonstrated technical ability regarding fundamental laboratory techniques and analytical methodology. The position requires but is not limited to the following: • Understanding of basic scientific principle, ability to communicate with peers and management; GMP/GDP experience• Effective organizational skills• Ability to multi-task and coordinate multiple activities in parallel• Developing problem solving skills• Developing instrument/method troubleshooting skills (HPLC/UPLC, CE, pH, UV-Vis, etc.)• Good working knowledge of operations/quality systems utilized in QC operations/support teams (eg; strong test method/scientific base)• Solid technical writing skills Education0-2 years of relevant experience (B.S. degree in biological science), 2+ years of relevant experience (A.S. degree in biological science) About BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies for the treatment of neurodegenerative and rare diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia. Founded in 1978, Biogen is one of the world s oldest independent biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for Alzheimer s Disease, amyotrophic lateral sclerosis (ALS), Parkinson s disease, spinal muscular atrophy and neuropathic pain amongst others. With more than 7,000 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States. Please be advised that all legitimate correspondence from a Biogen employee will come from "" email accounts. Job Segment: Biochemistry, Biotech, Quality Manager, QC, Science, Quality


Research Triangle Park, NC, US

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