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Associate II/III, Quality Control (Qualification Team) - United States
Posted on : 07 June 2017
- The Associate II/III is responsible for contributing to functional, tactical, and operational aspects of the QC qualification group at our company RTP facility.
- This includes coordinating and performing activities associated with qualification of standards, controls, and qualified reagents for use in QC Bio-assay testing, and activities associated with method assessments. Such activities include planning, coordinating, executing minimal qualification testing, data management and analysis, authoring and reviewing qualification protocols and reports, and authoring and reviewing method assessments.
- The Associate II/III should have an understanding of analytical methods, data analysis and interpretation, and have the ability to serve as a technical expert in bioassays/immunoassays (e.g. ELISA, cell based potency methods, AlphaScreen, etc.).
- Candidate should be proficient in their understanding of cGMP, Quality Systems, and have Knowledge of FDA/EMEA regulations and compliance and be able to apply that knowledge. The Associate II/III must have the ability to model the leadership competencies and work effectively independently, within a team framework, and across all business areas and levels of the organization.
- Coordinates/manages, and in some cases performs qualification testing
- Authors and reviews protocols and qualification reports, change controls
- Authors and reviews method assessment reports
- Provides technical oversight as a subject matter expert for the material qualifications and method assessments with minimal support
- Data management and analysis for qualifications and method assessments
- Interfaces with laboratory operations and other teams as appropriate for task
- Actively identifies gaps and areas for technical, process and quality improvement/innovation and supports or lead through implementation
- knowledge of quality systems
- Understanding of method validation with technical expertise in bioassays/immunoassays
- Statistical experimental design and data analysis with JMP and Excel Software
- Excellent technical writing/communication skills
- Data management
- Biological/Pharmaceutical drug processes
- Leadership competencies including follow-up, communication, collaboration, problem solving, and innovation
Biological Science degree is preferred with 3-5 years of relevant experience (MS degree) or 5+ years of relevant experience (BS degree)
- Through cutting-edge science and medicine, our company discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases.
- Our company 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).
- Our company 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.
- Our company was founded in 1978 and today serves patients in nearly 70 countries.
- 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 our company 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, our company is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.
- Our company is revolutionizing biologic manufacturing, developing the industry’s most advanced plants and processes.
- This expertise is used to produce both original innovative therapies and bio similar 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.
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