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Associate II/III, Quality Assurance Durham United States,
Posted on : 02 June 2017
|External Posting Title||Associate II/III, Quality Assurance|
|Job Description||The QA Associate II/III is responsible for contributing to the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. Activities include, but are not limited to: review of GMP raw data for compliance, review of GMP documentation to support batch disposition, review/approval of GMP procedures, protocols and reports, GxP Quality systems-related training, identify gaps in existing Quality systems and propose solutions. The QA Associate II/III will perform all duties in a manner consistent with site and Corporate policies, cGMP, safety, environmental and human resources policies and procedures, and adhere to all regulatory licenses and regulations. The QA Associate II/III interfaces with key Quality and manufacturing customers, coordinating deviations impacting the RTP site. The QA Associate II may participate in internal compliance audits; assess and approve discrepancies from site, corporate, and regulatory guidance. |
•Review and approval of batch related documentation (Master Production Records, Solution Lot records) to support product disposition.
•Review and approval of GMP documents (technical reports, procedures, workflows) to support manufacturing functional areas.
•Executes activities including: deviation and Global Change Control support.
•Supports resolution of both technical and compliance issues/gaps of moderate complexity.
•Aides in implementation of Quality Systems/System Improvements with some guidance, moderate technical problem solving (tools or enterprise systems) within function and across multiple functional areas.
•Supports and/or assists in GxP quality systems-related training. Provides some training within and across functions.
|Location||Research Triangle Park, NC, US|
•2-4 years industry experience in either Manufacturing or QA.
•General understanding of relevant FDA/EMA regulations.
•Must be resourceful and able to problem solve.
•General understanding of Quality role and concepts.
•Ability to develop solutions to issues of moderate complexity.
•Detail oriented aptitude and self-sufficient.
•General understanding of the manufacturing process.
•Excellent oral and written communication skills.
|Education||Bachelor of Arts/Science Degree in Life Science or other technical discipline|
|About Biogen||Corporate 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.
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.
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 "@biogen.com" email accounts.
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Research Triangle Park, NC, US
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