- Merck & Co. (Rahway, NJ)
- …reliability, safety and security requirements appropriate for industrial environments. Requirements definition & systems design Lead scoping, requirements ... requirements ; manage risks from integrations and on-prem/edge control systems . Collaborate with Infrastructure, Cybersecurity and Architecture teams to define… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Assurance teams to ensure training programs support overall quality management systems Physical Requirements Approximately 20% overnight travel. Qualifications ... affairs Maintain training assignments on clinical research documentation, regulatory requirements , Good Clinical Practice (GCP), and medical affairs procedures… more
- Aequor (Indianapolis, IN)
- …and fact-finding combined with a basic understanding of user needs and business systems and industry requirements ; Creates process change through the integration ... a senior level Business Analyst to review, analyze, and evaluate business systems and user needs. Complete Description: Local candidates to Indianapolis only. About… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …established internal contacts.Consistently perform tasks in adherence with safety policies, quality systems , and cGMP requirements , as well as according to state ... and federal regulatory requirements .Strive to reduce non-conformances in supported areas by dedicatedly...response to potential findings.Ability to utilize multiple electronic quality systems and SAP.Contribute to the improvement of QA practices… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and audits as needed.Consistently perform tasks in adherence with safety policies, quality systems , and cGMP requirements , as well as according to state and ... to use on the manufacturing floor.Utilize multiple electronic quality systems , batch records and SAP.Work in a team based,...federal regulatory requirements .Other duties will be assigned, as the need arises.Job… more
- Insmed Incorporated (San Diego, CA)
- …21 CFR Part 11, and CDISC ODM Standards.Data Quality & Compliance: Ensure EDC systems comply with regulatory requirements (eg, FDA, EMA, ICH-GCP) and company ... role will be responsible for the development and implementation of EDC systems to support clinical trials, ensuring data quality, compliance, and efficiency… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …needs.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements .Other duties will be assigned, as necessary.Works ... ongoing laboratory investigations.Maintain detailed knowledge of industry guidelines/trends, regulatory requirements , and applicable pharmacopeia while remaining current in on-the-job… more
- BWX Technologies, Inc. (Lynchburg, VA)
- …concise, verifiable requirements . + Must have general understanding of Systems Requirements , Architecture, Interface Definition, and Design. + Must have ... researches, designs, and develops innovative new nuclear reactors, nuclear rocket propulsion systems , and radioisotope production systems for both internal and… more
- Infinity Systems Engineering (Colorado Springs, CO)
- …ideal candidate will contribute to the definition, analysis, and validation of systems architecture and requirements using industry-standard MBSE tools and ... + Develop, maintain, and analyze system models using MBSE tools (eg, Cameo Systems Modeler, MagicDraw, CAD). + Translate stakeholder requirements into system… more
- Merck & Co. (Rahway, NJ)
- …Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of Excellence (COE) is responsible and accountable for ... molecule bulk and primary packaging components and packaging master data and systems .The Packaging Technical Operations organization aims to be an industry leader in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Practices (GDP).Perform tasks on time in a manner consistent with quality systems and cGMP requirements .Work in a team based, cross-functional environment ... assigned curriculum.Accountable for maintaining a working knowledge of basic cGMP requirements to ensure adherence to compliance policies and regulationsWear the… more
- Insmed Incorporated (NJ)
- …biologics, drug products, or combination products.Deep knowledge of phase-appropriate quality systems , regulatory requirements (21 CFR Parts 210/211, 600s, 820, ... programs.Participate in Quality governance forums, providing expert input on GMP requirements and ensuring alignment with global Quality strategy.Lead and develop a… more
- Insmed Incorporated (NJ)
- …we're in. Are you? About the Role:We're looking for a Summer Intern - Digital Systems QA on the Quality Assurance Team to help us expand what's possible for patients ... with serious diseases. Reporting to the Associate Director, Quality Systems , you'll leverage your data science and AI skills to identify and implement AI/ML… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …tasks on time in a manner consistent with safety policies, quality systems , and cGMP requirements .Build strong partnerships with Manufacturing, Warehouse, ... production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …tasks on time in a manner consistent with safety policies, quality systems , and cGMP requirements .Build strong partnerships with Manufacturing, Engineering, and ... production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and internal stakeholders to execute audits effectively. Ensure the internal systems auditing program fulfills regulatory requirements performs audits, ... responsible for end-to-end GxP relevant audit activities that encompasses the internal systems and processes of the Daiichi Sankyo's GxP group.Together with regional… more
- Applied Research Solutions (Bedford, MA)
- …and CC (Critical Components) analysis. + Recommend and review Tempest requirements , systems security contingency plans and disaster recovery procedures. ... **Description** ARS is seeking a Senior Information Systems Security Engineer (ISSE) candidate located at Hanscom,...the acquisition process and how it's used to generate requirements ; how RMF and Cybersecurity should be covered in… more
- Premera Blue Cross (Mountlake Terrace, WA)
- …Genesys Cloud platform. + Advise and act as resource for complex, interconnected systems projects, evaluate requirements and offerings and ensure work aligns ... enterprise-wide systems , lead the integration of multiple systems and services, setting standards and requirements ...multiple systems and services, setting standards and requirements to ensure alignment to best practices. + Evaluate… more
- Tyto Athene (Washington, DC)
- …Officer (ISSO)** with privacy experience. The candidate will ensure that security requirements for information systems meet FISMA requirements . Assist ... mandated privacy laws, regulations, policies, and procedures to the specific privacy requirements , be knowledgeable in federal privacy laws and regulations and their… more
- InterSources, Inc. (Atlanta, GA)
- …formats. Work closely with end users to analyze, define, model, and document systems requirements . Identify project milestones, phases, and elements, and keep ... interfaces across multiple courts, with a variety of existing databases, and reporting systems . The Judicial Council of Georgia / Administrative Office of the Courts… more
