4 manufacturing jobs found in Rensselaer, NY

We are currently looking to fill a Quality Assurance Specialist position to support the Manufacturing Execution System (MES). This position will support a cross functional team of MES Specialists by providing a QA perspective with regards to manufacturing business processes, documentation requirements, and overall design of records. We are looking for someone who can continuously provide QA input and feedback in accordance with regulations, policies and procedures. In this role, a typical day might include the following: Reviewing company documentation including SOPs, SPECS, Process Transmittals, and Manufacturing Batch Records to assess MES impact Identifying difficulties and suggesting alternatives that are aligned with QA Reviewing MES change controls and test plans Working with Technical Trainers to develop QA training plans for MES users Collaborating in the creation, review, and approval of validation documents Reviewing and approving MES recipes, master...

We are currently looking to fill a Principal GMP Data Governance Specialist position. This role plays a pivotal part in ensuring that Regeneron’s Data Governance systems and practices meet the highest standards of regulatory & industry compliance. The post-holder is responsible for providing specialized knowledge and expertise in the design of Data Governance (DG) frameworks, policies & procedures that are aligned with regulatory requirements and industry standards.     In this role, a typical day might include the following:   Assess current and evolving regulatory guidance & industrial intelligence in relation to IOPS business practices.   Subject Matter Expert (SME) for authoring and developing the standards, policies and procedures in line with regulatory requirements and industry best practices . Technical writing, research, and related editing activities, ensuring accuracy and consistency of documentation and that the...

We are hiring a QA Specialist for our Technical Transfer Start Up Team (TTST). As a QA Specialist you will provide QA oversight in the TTST to ensure manufacturing documentation a nd implementation aligns with Process Transmittals and meet the requirements of Regeneron’s quality system. In this role, typical day may include: Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution. Train and/or mentor junior employees, including providing insights and education on processes and procedures. Provides consultation or advice in alignment with QA policies. Review, edit, or approve Regeneron controlled documents. Review and approval of investigations associated with raw materials, product, laboratory, facilities, and materials. Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement. Responsible...

We are currently looking to fill a Quality Assurance Specialist position. This position performs activities supporting dispositioning product and/or raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. In this role, a typical day might include the following: Representing Quality Assurance in support of sophisticated Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution  Participate as a QA representative on Technology Transfer Startup Teams where responsibilities include providing guidance on QA procedures and polices as well as review of documents for both internal and external transfers Providing consultation or advice in alignment with QA policies Reviewing completed records and batch sheets and working with other departments and communicate internally (Tarrytown, Raheen) and externally...