6 specialist is business system analyst jobs found

Regeneron is currently looking for a Principal QC (Quality Control) Micro Specialist to join our Micro Tech Team. This position will specialize in in developing QC microbiology test methods; provide critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. Ensure departmental compliance to regulatory guidelines are maintained.  Drives continuous improvements for microbiological methods. As a Principal QC Micro Specialist , a typical day might include the following: Identification, introduction, onboarding and initial qualification of alternative and rapid technologies applicable to microbiological assays and procedures. Become the SMEs of this technologies, assays and procedures. Coordinating Test Method validations, studies, and troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CLOs. All these efforts may gain complexity overtime. Builds processes where gaps have been...

The Sourcing Specialist will be responsible to support assigned categories and is a proven collaborator who can work with cross functional teams across Regeneron, locally, regionally and internationally. Essential Duties and Responsibilities include, but are not limited to, the following: Being accountable for supporting the definition and implementation of the assigned categories strategy to serve global and regional business needs as assigned. Working closely with stakeholders to support discussions related to the assigned categories and aligns category priorities with Procurement management and stakeholders. Supporting negotiations, supplier management activities, and stakeholder engagement activities for the Categories as assigned. Taking direction to drive value in terms of cost savings, cash flow improvement, and other efficiency savings from category management activities. Supporting Global Procurement by participating in organizational decisions in the...

Regeneron is currently looking for a QC (Quality Control) Micro Specialist to join our QC Microbiology Tech team. This is a lab based position that will specialize in developing new QC microbiology test methods; provide critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. This position will be actively involved in supporting Change Controls, data review, and compliance records for the microbiology verification team. Ensure departmental compliance to regulatory guidelines are maintained.  Drives continuous improvements for microbiological methods.    As a QC Micro Specialist, a typical day might include the following:   Leading Test Method verifications, designing studies, and assisting on troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CLOs. All these efforts may gain complexity overtime.  Implement verified methods...

Regeneron is looking for a Compliance Specialist to join our Process Sciences Change Management team. This is a non-lab-based position.  This position will be responsible for supporting the Process Sciences, Manufacturing, and CMC Regulatory departments through the development of strategic plans to support change management activities and documentation related to implementation and maintenance of process control programs for bulk drug substance / formulated drug substance, drug product, combination product, and advanced therapies manufacturing bioprocesses. In this fast-paced environment with a strong pipeline, our Compliance Specialists have an opportunity to work on countless aspects of the process and business. As a Compliance Specialist, a typical day might include the following: Craft business plans to independently advance change control initiatives to implement lifecycle activities of established manufacturing control strategies in support of Global Process...

As a Senior Specialist, Global Procurement you will support the planning and execution of procurement initiatives using the procure to contract process for Regulatory Affairs & Health Economics and Outcomes Research. This position will conduct data gathering, support spend analytics, assist in delivering measurable cost savings, and monitor savings against contract. You will support evaluations through the development of RFQs, RFIs and RFPs, collectively RFx, and may participate in negotiations. The Senior Specialist will support all vendor sourcing activities which includes but is not limited to preparing QBR data and measuring supplier performance.  A typical day may include the following: Works to support procurement and category management-related initiatives.  Use sourcing system tools and techniques to meet business needs and issues while supporting collaborators and category teams. Provides comparative financial analysis when required for sourcing & procurement...

This role supports and maintains compliance of QA Operational Team, inclusive of but not limited to QA Operations; Document Control; QA Raw Materials and QA Systems with mandated regulatory requirements and site expectations. As a QA Specialist/ Sr QA Specialist a typical day might include, but is not limited to, the following:   Maintaining regulatory compliance in accordance with current Good Manufacturing Practices (cGMP). Collaborating with Cross functional teams to resolve issues, complete investigations and maintain compliance. Reviewing and approving of the following types of documents: Failure investigations associated with deviations, Corrective and preventative actions (CAPA), Standard operating procedures (SOP’s), GxP documents & Change control documents. Supporting root cause analysis ensuring appropriate CAPA are implemented to prevent recurrence where relevant as a quality approver. Reviewing procedures, policies and other...