14 procedural specialist jobs found

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Sr. Logistics Compliance Specialist, International will support efforts as it relates to international product movements, dangerous goods / hazmat regulatory adherence, and audit-ready process management. The incumbent will be the SME and primary point of contact for International Trade regulations supporting our product movements into/out of all countries we operate in, and supporting International Product Rollouts in all global regions. This role will be responsible for identifying import and export requirements in various countries, summarizing and managing regulatory...

Within this role you will support the Process Sciences laboratory operations by supporting adherence to site policies and procedures associated with but not limited to good documentation practices, data integrity considerations, equipment and vendor maintenance and PS study execution, recording and reporting. As a Compliance Specialist within Process Sciences, a typical day might include, but is not limited to, the following:   Ensuring oversight and support for PS laboratory operations comply with site data integrity policies and procedures. participating in ATRAs, audit trails reviews, data recording, storage, and verification Maintaining laboratory records in accordance with site procedures is essential. Types of records include paper and electronic lab notebooks, laboratory logbooks, equipment maintenance records, and laboratory study protocols and reports Completing quality records such as deviations, CAPAs, and change controls with support and oversight...

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...

We are currently looking to fill a Facilities Compliance Specialist (Technical Writer) position. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Facilities Compliance Specialists ensure cGMP compliance for the Facilities Management Department. *This is an onsite position located in Rensselaer, NY* As a Facilities Compliance Specialist, a typical day might include the following: Acting as a liaison between the Facilities Department and onsite quality and regulatory groups to define and address all issues of non-compliance Managing and participating in Facilities Department issues of non-compliance to ensure all activities related to the investigation and resolutions of non-conformities are performed in a timely manner...

Within this role you will be responsible for coordination and completion of manufacturing deviations and change controls.   As an Associate / Compliance Specialist a typical day might include, but is not limited to, the following:   ·          Coordinating and documenting of manufacturing quality events including but not limited to deviations and change control’s ·          Coordinating cross functional teams during Change Control/Deviation events and align team on approach forward ·          Utilizing problem solving methodologies such as fishbone, 5 Whys to establish root cause of deviations ·          Working closely with Manufacturing Managers to review and evaluate quality event information ·          Assessing event for impact to SISPQ, conduct risk assessments and initiating appropriate corrective actions to prevent recurrence ·          Coordinating of internal reviews of investigational reports ·...

Within this role you will support and maintain all cGMP compliance aspects of Strategic Sourcing & Procurement (SS&P) operations under the direction and guidance of sourcing management. You'll ensure organization and timely completion of Approved Supplier List documentation in addition to process deviations assigned to sourcing (CAPAs, NOEs, EOEs) and support closure of QA Audits related to audits of raw material manufacturers and distributers. This is a 12-month temporary contract position. As a Compliance Specialist, a typical day might include, but is not limited to, the following:   Supporting and proactively maintaining all procurement cGMP procedures, documentation and training related to SOP and Work Instructions Maintaining and managing the Approved Supplier List (ASL) Addressing compliance needs and coordinating with other sites to ensure engagement, feedback and buy in related to procurement document revisions Driving successful...

In this role you will act as a bridge between global policy and standard setting and the local implementation of these within the site business unit(s). Your role will play a fundamental par t in safeguarding the quality and reliability of the organisation’s data which is essential for informed decision making and regulatory compliance. In this role, a typical day might include the following: Successful building, leading and managing of the site Data Operations &  Engagement, C ulture & Monitoring (ECM) t eam Successful delivery/implementation of site data governance (DG) responsibilities and standards   Responsible for successful stakeholder engagement and management across the site   Responsible for establishing a successful relationship with the global Governance Team (Policies & Programs) so a clear feedback loop is established     Responsible for the...

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...

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...

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...

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...

We are currently looking to fill a Principal External Manufacturing Specialist role. The External Manufacturing Principal Specialist provides technical and process support for all aspects of clinical and commercial parenteral drug product operations in the External Manufacturing Network. Coordinates all aspects of manufacturing operations including oversee day-to-day operations, ensure timely completion of associated operations/documentation, and assist in the monitoring of cGMP compliance at drug product contract manufacturers.   As a Principal External Manufacturing Specialist, a typical day may include the following: Serve as the primary Regeneron technical contact for select DP contract manufacturing sites concerning day-to-day activities. Liaison between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners. Ensure the timely routing and review of all master manufacturing records...

The Data Governance (DG) ECM champions a culture of data governance within their site by ensuring compliance with DG policies; crafting and delivering relevant training; and monitoring DG practices. The role is pivotal in promoting data stewardship, improving data quality and ensuring DG principles are embedded in the site culture. As a Senior GMP Data Governance & Engagement Specialist, a typical day might include the following: Working in conjunction with the Global DG (Policy & Programs) Team to craft & deliver continuous DG Training in line with current and evolving required DG knowledge, skills and awareness needs. This includes: Crafting, developing & delivery of comprehensive training programs focused on DG, compliance with regulations, and standard methodologies for bio-pharmaceutical manufacturing while using e-learning platforms, simulation tools, and virtual training environments Assess industry trends and regulatory updates on training needs and...

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...