11 jobs found in Tulsa, OK

Within this role you will be responsible for the configuration, implementation, maintenance, and ongoing support of various IT applications and systems.   As an IT Applications Analyst , a typical day might include, but is not limited to, the following: Coordinating across business departments and stakeholders, gathering, and implementing requirements and enhancement requests for various applications Providing SME support and working closely with cross-functional departments on projects to enhance system functionality and solving emergent issues Coordinating with other IT Application team members to administer and support production systems in an efficient and compliant manner Handling IT Application documentation tasks, including converting user requirement specifications to a detail design specification, creating configuration test plans, and compiling summary reports Configuring reports (tabular, trend, and labels) Processing IT Applications change control...

As an Automation Engineer you will be responsible for d esigning, building and maintaining digital infrastructure platforms to drive innovation by making informed decisions using real-time data and information. A typical day might include, but is not limited to, the following: Designing and delivering end-to-end data solutions to meet our current and future needs Facilitating the smooth transition of projects from development into production environment Overseeing migration of data from legacy systems to new applications Acting as a subject matter expert and the technical go-to for the data integration solutions Becoming intimately familiar with the data model of the process systems Iterating and shipping ideas quickly with minimal direction Collaborating effectively with other functions and groups on the sites data strategy Reviewing requirements, specifications and technical design documents to provide timely and meaningful feedback...

The Staff IT Operations Reporting Specialist ensures the delivery of high-quality services to end users, with a focus for developing, managing, and optimizing reporting processes to support operational excellence in a highly regulated GxP environment. This role requires a deep understanding of data analytics, reporting tools, and the ability to translate complex data into actionable insights. You will work closely with key stakeholders, including sponsors, to understand their reporting requirements and develop tailored solutions using Power BI, Splunk and Tableau, aligning to the company’s methodologies and ways of working. A typical day might include, but is not limited to, the following: Collaborating with cross-functional teams, senior stakeholders and sponsors to gather reporting needs and translate them into actionable digital solutions from the ground up Leading the design, development, and implementation of innovative performance dashboards using Power BI, Tableau...

In this role you will be responsible for fostering a culture of data governance (DG) within the site by ensu r ing compliance with Data Governance policies ; designing and delivering relevant training ; and monitoring Data Governance practices. The role is pivotal in promoting data stewardship, enhancing data quality and ensuring the principles are embedded in the site culture.   In this role, a typical day might include the following: Work ing in conjunction with the Global DG (Policy & Programs) t eam to d esign and deliver c ontinuous DG Training in line with current and evolving required DG knowledge, skills and awareness needs . This includes:   Designing and developing comprehensive training programs focused on DG , compliance with regulations, and best practices for bio- pharmaceutical manufacturing   Conduct training needs assessments to identify training gaps and areas...

In this role you will play a pivotal part in ensuring that Regeneron’s Data Governance (DG) systems and practices meet the highest standards of regulatory and industry compliance. You will be r esponsible for providing specialised knowledge and expertise in the design of ( DG) frameworks, policies and procedures that are aligned with regulatory requirements and industry standards.   In this role, a typical day might include the following: Assessing current and evolving regulatory guidance and 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 appropriate approvals are received   Generating and...

As a IT Applications Analyst (MES) you will be in a business facing role responsible for the configuration, implementation, maintenance and ongoing support of our MES (Manufacturing Execution Systems) areas.  A typical day might include, but is not limited to, the following: Coordinating across business departments and stakeholders to gather and implement enhancement requests Identifying and resolving system issues and appropriately communicating items to management, business process owner and users Responsible for IT Applications documentation including converting User Requirement Specifications to a Detail Design Specification, writing Configuration Test Plans and summary reports Configuring reports; tabular, trend and labels Performing daily business administrative tasks related to functional support and general user account administration Providing SME support and working closely with functional departments on projects to develop, implement and enhance the system...

The Manager QA Validation is responsible for qualification of equipment, utilities, software, and validation of cleaning and sterilization processes in Regeneron’s Raheen facility. A typical day might include, but is not limited to, the following:   Designing and developing policies for validation and ensuring that they are effectively administered and comply with regulatory requirements Leading all aspects of QA validation including reviewing and approving of the following types of documents, relating to area functions: Failure investigations, Change controls and associated Test Plan documentation, SOPs, Validation protocols and summary reports, Validation Master Plans Managing Validation Department personnel by developing validation work plans, establishing objectives, and assigning tasks Developing and managing validation budget, contracts, and schedules Presenting and defending validation data to FDA and other regulatory agencies Maintaining validation...

In this role you will be responsible for providing QA oversight and support to manufacturing activities.  Performs and leads activities in support of dispositioning product while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. The successful candidate will be required to work shift which includes a mix of days & nights As a QA Specialist a typical shift might include, but is not limited to, the following: Providing QA oversight & support to manufacturing activities within the manufacturing areas to support: Issue resolution in conjunction with key stakeholders, including:  Quality point-of-contact for troubleshooting and documentation of equipment/process/schedule disruptions, Triage of potential non-conformances including securing necessary documentation for investigation team in real-time, Support of/counter signing annotations, Perform area walkthroughs, Provide oversight and...

The Quality Assurance Manager will perform GQP duties related to the distribution and launch of pharmaceutical products under the Associate Director of Quality Operations (Hinseki). This role will work under the direction of the Associate Director to perform the implementation and will work with Regeneron global folks to execute of the Regeneron Quality Management System relating to good distribution practices (GDP) and product release. There will be significant engagement and collaboration with Global IOPS (Industrial Operations and Product Supply) teams. In accordance with the GQP General Rules for Quality Assurance Operations, you may be asked to act as a substitute in the absence of Hinseki. Responsibilities will include, but are not limited to, the following : GQP & GMP Quality Assurance • Quality Management: GQP QA Release, Inspection, Change Control, Deviation • Creation and maintenance of Quality Agreement for Supplier • Correspondence of the quality complaint,...

The individual in this position implements policies and procedures to qualify IT infrastructure platforms and validate computer systems. Plans, coordinates, and participates in a compliant qualification process for qualifying information technology infrastructure platforms which requires formal qualification documentation under appropriate regulatory requirements and company standards.   As a Sr QA Validation Specialist (IT Infrastructure) typical day might include, but is not limited to, the following:  Analysing the results of testing and determines the acceptability of results against predetermined criteria Investigating and troubleshooting problems which occur and determines solutions or recommendations for changes and/or improvements Identifying current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation vital to...

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...