IT Quality / Sr. IT Quality Assurance Associate - United States
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- As a member of the IT Quality team, the IT Quality/Sr. IT Quality Analyst helps to define, plan, and perform duties that support major system development life cycle activities, including validation review and change control approval of IT systems spanning GMP and GCP/GLP Applications (GxP).
- The IT Quality / Sr. IT Quality Analyst is required to attend department and user meetings, system assessment meetings, trainings, and other essential tasks.
- Night and weekend support is required for system deployments.
- The IT Quality Analyst must maintain a professional manner in representing the company and in working with its agents and associates.
- The IT Quality / Sr. IT Quality Analyst should demonstrate initiative and self-direction while also knowing when to seek assistance.
- This person must also be able to routinely schedule and complete multiple tasks and be timeline driven.
- The individual must focus on ensuring consistent policy administration, implement key improvement initiatives and solve compliance issues in partnership with business owners.
Summary of Key Responsibilities:
- Approve system life cycle deliverables (SDLC) and activities to ensure that procedures and methodologies are followed and that appropriate and complete documentation is captured and reported to support SDLC activities for assigned IT systems, including associated change requests.
- Represent IT Quality on all assigned IT projects in support of SDLC activities.
- Consult on the authoring and conformance of SDLC deliverables and activities in regards to corporate SOPs, policies and current regulations.
- Provide guidance, training, and support to IT personnel in their SDLC efforts, to ensure compliance.
- Provide quality assurance oversight for system related issues
- Act as a high-level technical resource to IT quality and customer base for interpretation of policy, review and approval of technical documents, and high level decision making.
- Employ risk-based methodology, where feasible and achievable.
- Knowledge of IT Controls methodologies, including GAMP5 and ITIL
- Well-versed in GxP guidance, including 21 CFR Part 11, Annex 11 and Data Integrity
- Experience with system validation across GxP landscape, specifically R&D applications
- Excellent communication skills, both verbal and written as well as capable of presenting the right level of information to senior management
- Knowledge of the IT system development life cycle and software quality assurance in a regulated environment
- Knowledge of general software and database concepts
- Ability to work both independently and with teams at various levels in the organization
- Ability to work in a very dynamic environment with a clear sense of urgency.
- Exercises considerable independence in determining objectives and approaches to assignments
- Excellent organizational skills and attention to detail and accuracy
- Life Sciences biotech / pharmaceutical experience
- Experience in HP ALM ideal.
- Experience supporting health authority inspections a plus.
- 7+ or more years working in an IT SQA or Quality role. Must have hands-on IT experience and in-depth knowledge of FDA and International Regulations.
BA/BS required in Life Sciences or IT related discipline
- 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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