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Associate I/II, Quality Control
Biogen | Research Triangle Park, North Carolina
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Job Description

External Posting TitleAssociate I/II, Quality Control
Job DescriptionThe QC Associate is responsible for supporting the QC team in functional, tactical, and operational aspects at the Biogen RTP facility. This includes activities associated with equipment & instrument maintenance: conducting (PM) Preventative Maintenance, scheduling CM (Corrective Maintenance work orders), assist with change controls, decommissioning and life cycle. Adhere to schedules, deliverables, and will be responsible for proper administration and adherence to all Biogen policies & procedures. Additional responsibilities include management of projects, adherence to all regulatory regulations, interfacing with I&C, validation, lab operations teams & global instrument group. Writing, coordination and review of OOT (RAR's) impacting the QC equipment and instrumentation. Support the laboratory operations teams for activities related to equipment management, purchase, standardization of systems. Ability to work effectively within the group, within Quality, across site and with other departments. This requires solid written and verbal communication skills.

Responsibilities include but are not limited to:

•Initiating instrument maintenance records, decommissioning protocols, other equipment related protocols, RAR reports, change control, AIV validation protocols & report, as applicable. Ensures compliance with instrument & equipment platform, procedures and Global QC vision.

•Participates in core functions of team related to equipment & instrument projects; provides technical support as well as facilitation of team tasks such as document revisions.

•Coordinates QC lab support projects related to instrumentation & equipment with other departments; provides updates to QC supervisor. Works closely with QA, Global Instrument team, Maintenance, Metrology I&C, etc. Supports and helps to design effective laboratory systems and life cycle to ensure integrity of all laboratory instrumentation and equipment programs.

•Ability to flex and respond to unexpected situations/demands; raise issues appropriately as well as provide resolution, as necessary.
LocationResearch Triangle Park, NC, US
Job CategoryQuality
Requisition Number31528BR
QualificationsLevel I: 0-2+ years in comparable, related role for GMP laboratory operations. Able to use computerized systems, basic instrument life cycle concepts.

Level II: 3 - 4+ years in comparable, related role for GMP laboratory operations, understanding of instrumentation, equipment.

Good working knowledge of GMP laboratory operations, Biogen quality systems, understands work processes of QC lab equipment, instrumentation (e.g.; strong instrument/scientific base). Completes deliverables, able to draw conclusions from data interpretation. Solid technical writing skills, authors reports with input & guidance and conducts work impact assessments, as appropriate. Can utilize computerized systems, EAM, Trackwise, Temperature excursion trending software. Initiates improvements, supports management & QC teams.
EducationAssociate's degree, Bachelor's degree (B.S.) in science discipline
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.

One of the pioneers in biotechnology, Biogen was founded in 1978 and today serves patients in nearly 90 countries. Our global headquarters and R&D operations are located in Cambridge, Massachusetts, with an international headquarters in Zug, Switzerland, world-class manufacturing facilities in Research Triangle Park, North Carolina, USA and Hillerod, Denmark, and affiliate locations around the world.

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 "@biogen.com" email accounts.

About Biogen

Biogen Idec Inc. is engaged in the development, manufacturing, and commercialization of therapies. The Company's products address diseases such as multiple sclerosis, lymphoma and rheumatoid arthritis. The Company has four products: AVONEX (interferon beta-1a), RITUXAN (rituximab), TYSABRI (natalizumab) and FUMADERM (dimethylfumarate and monoethylfumarate salts). AVONEX is used in the treatment of relapsing forms of multiple sclerosis (MS). RITUXAN is used in the treatment of relapsed or refractory low-grade or follicular, CD20-positive, and B-cell, non-Hodgkin's lymphomas (B-cell NHLs). TYSABRI is approved for the treatment of relapsing forms of MS. FUMADERM acts as an immunomudulator. It also has product candidates, such as BG-12 (acquired with the purchase of Fumapharm), ANTI-CD80 antibody/(galiximab), ANTI-CD23 antibody/(lumiliximab), Ocrelizumab/(Humanized ANTI-CD20 Antibody) and Lixivaptan.In January 2007, the Company completed the acquisition of Syntonix Pharmaceuticals, Inc. (Source: 10-K)

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