QA Data Analyst
We are currently looking to fill a Quality Assurance (QA) Data Analyst. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our QA Data Analysts develop and maintain data analytics tools and predictive modeling algorithms to analyze aspects of the Quality Systems (QS). They work closely with the business partners and QA Management to ensure that the QS are meeting current business needs and are strategically positioned for future growth and expansion.
As a QA Data Analysts, a typical day might include the following:
• The individual will also provide direction and guidance to ensure that QS are aligned with current and future stakeholder needs and adhere to regulatory and Regeneron polices.
• Identify and extract datasets to observe the impact of the QS across the business and with regulatory agencies.
• Understand and explore the workflow of the QS to identify potential bottlenecks and areas of improvement.
• Collaborate with management to continuously assess and adjust programs and processes.
• Develop proposals and strategies related to future-planning and growth of the group.
• Design and build a metrics framework to grow the QS and create data-driven decisions.
• Work closely with the IT Data Analytics team and Qlik Business Partners to maintain data quality from development to production.
• Collaborate with multiple internal customers to build ad hoc reports and analytics and provide the training and know how to be the owners of their own data.
• Learn and incorporate new technologies and ideas into the way the QA Data Team functions daily.
• Continuously improve and maintain dashboards to create visualizations to help drive the business.
• Requires US site travel 10-20% and international site travel 5-10%.
This role might be for you if you:
• Understand the overall biopharmaceutical product development process
• Comprehend quality and cGMP/GxP principles and Quality Management Systems and business operations
• Understand Python/R packages for developing statistical models.
• Use Spark and Python libraries for machine learning.
• Possess rigorous attention to detail, strong organizational and communication skills.
• Have experience with SharePoint design and workflow implementation.
• Possesses fundamentals in motivating, communicating with and instructing/training others, using both technical and non-technical language to explain simple subjects and processes.
• Are comfortable making simple decisions independently but demonstrate good judgment in raising issues to management and QA colleagues.
• Negotiate and influence without direct line authority.
• Adept in analyzing information of considerable difficulty and drawing valid conclusions and researching and gathering information related to customers, processes, systems.
• Have strong interpersonal skills.
• Are a good technical writer.
• Manage multiple tasks and ensure on-time completion.
• Think creatively, proactively and propose solutions with attention to detail.
• Effectively communicate issues and ideas with peers and with management.
• Facilitate meetings with cross-functional teams.
• Solid understanding of word processing, spreadsheet, database management and presentation software.
To be considered for the QA Data Analyst you must have the following; at Associate level a BA/BS degree in an IT/quality/engineering/science discipline or equivalent combination of education and experience. Specialist level a BA/BS degree in an IT/quality/engineering/science discipline and 2 years of relevant experience or equivalent combination of education and experience. Senior Specialist a BA/BS degree in an IT/quality/engineering/science discipline and 5 years of relevant experience or equivalent combination of education and experience. Data analysis experience in a cGMP environment is preferred. Level is determined based on qualifications relevant to the role.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.