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Associate I/II, Quality Control - United States  

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Posted on : 02 June 2017

Project Description

External Posting TitleAssociate I/II, Quality Control
Job DescriptionThe QC Associate I/II is responsible for supporting key functional, tactical, and operational aspects of the QC Chemistry 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, effective interactions/communication with Quality management, personal development, and support of investigations. The incumbent should be able to work effectively within the group.

• Performs release and stability testing

• Authors protocols, change control requests, and Quality Technical Reports, as directed etc. Provides technical leadership as a subject matter expert in one or more disciplines

• Provides timely review/corrections for data and documentation generated for or by QC Chemistry

• Participates in the execution of method transfer, method development, method qualification, analytical improvement projects, and validation of analytical methods in collaboration with teams as appropriate

• Supports maintenance of effective laboratory systems to ensure integrity of all laboratory results
LocationResearch Triangle Park, NC, US
Job CategoryQuality
Requisition Number31698BR
QualificationsThe QC Associate I/II 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

• Effective organizational skills

• Ability to multi-task and coordinate multiple activities in parallel

• Developing or demonstrated problem solving skills

• Developing or demonstrated instrument/method troubleshooting skills

• Good working knowledge of operations/quality systems utilized in QC operations/support teams (eg; strong test method/scientific base)

• Solid technical writing skills
EducationAssociate I Requirements:
0-2 years of relevant experience (B.S. degree), 2+ years of relevant experience (A.S. degree)

Associate II Requirements:
0-2 years of relevant experience (M.S. degree), with 3+ years of relevant experience (B.S. degree), 4+ years of relevant experience (A.S. degree)
About BiogenCorporate Overview
Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS). Biogen also manufactures and commercializes biosimilars of advanced biologics. Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.
  • Biogen was founded in 1978 and today serves patients in nearly 70 countries.
  • A Fortune 500 company, Biogen in 2016 had revenues of $11.4 billion
  • Global headquarters in Cambridge, MA, and international headquarters in Zug, Switzerland
Our Science
We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry. To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.
  • For nearly two decades Biogen has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world. Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease.
  • We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer’s disease, Parkinson’s disease, and ALS.
  • As we uncover new insights into human biology, Biogen is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.
  • Biogen is revolutionizing biologics manufacturing, developing the industry’s most advanced plants and processes. This expertise is used to produce both original innovative therapies and biosimilars that expand patient access to lower-cost medicines.
Our Corporate Citizenship
The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion. As a company, we are focused on improving science education and limiting the impact of our company on the environment. In 2015, we became a carbon neutral company and ranked first place on Newsweek’s 2015 Green Rankings, and we are an industry leader on the Dow Jones Sustainability World Index. Biogen was named to Science’s list of Top Employers of 2015 and in 2017 received a perfect score of 100 for the fourth consecutive year on the Human Rights Campaign (HRC) Corporate Equality Index, which also named Biogen as one of its Best Places to Work.

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.

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