gxp Jobs in illinois

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Medical Device Engineer

Katalyst Healthcares and Lifesciences

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North Chicago, Illinois, USA

Full-time

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabi
Posted 18 days ago | Updated 4 hours ago

Lead Engineer - MES Opcenter

Katalyst Healthcares and Lifesciences

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Remote or New York, USA

Full-time

Job Description: The Lead Engineer will lead a team of technical resources to design, develop, configure, and test MES (Manufacturing Execution Systems) solutions. They will be directly responsible for leading resources contracted vi third-party and through other Pharmaceutical organizations to develop & deploy MES application software to Medical Device manufacturing sites globally. Responsibilities: Act as subject matter expert on system design and architecture. Solutioning and designing new
Posted 34 days ago | Updated 4 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments Test planning and strategy creation and execution of test protocols, scripts and reports. V
Posted 60+ days ago | Updated 4 hours ago

RWE Data Scientist II

Katalyst Healthcares and Lifesciences

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North Chicago, Illinois, USA

Full-time

Job description: As a Real-World Data (RWD) Scientist , you will be part of a team powering data driven insights that lead to better, faster decisions and therapies for our patients. Acting as a lead data scientist in your project area, you will contribute RWD expertise to broader cross-functional initiatives. Candidates should be excited to drive innovation by implementing new business technology solutions that solve significant scientific or business problems through the use and understanding
Posted 60+ days ago | Updated 4 hours ago

Senior Director IT Quality Assurance & Compliance

Regeneron Pharmaceutical

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Remote or Sleepy Hollow, New York, USA

Full-time

As a Senior Director of IT, Quality Assurance and Compliance, you will lead a team of those managing 20 to 30 members The focus is to provide leadership, coaching, and technical support to the IT QA & Compliance Management Team. This role is an on-site position 4 days/week at our Sleepy Hollow, NY or Warren, NJ office. There will be occasional travel to other sites in the Rensselaer, NY area. If eligible, we can offer relocation benefits. We are unable to offer a fully remote option. A typical
Posted 45 days ago | Updated 4 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana
Posted 60+ days ago | Updated 4 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

•

Libertyville, Illinois, USA

Full-time

Responsibilities: The Manufacturing IT Systems Quality & Compliance Specialist- Cell Therapy Manufacturing Systems supports the successful operation of manufacturing and business functions at Libertyville site through interaction with internal team members, peer and higher-level customers as well as external service providers. The individual is responsible for the development of and adherence to system governance procedures. The individual supports multiple IT projects/systems and ongoing work a
Posted 60+ days ago | Updated 4 hours ago

Senior Manager, Data Analytics

Quest Diagnostics Inc.

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Chicago, Illinois, USA

Full-time

Job Description Reporting to the Director, Program Management QA/RA, the Sr. Manager, Data Analytics - Quality & Regulatory Affairs will lead the development, management, and execution of a best-in-class analytics strategy in support of the QA/RA function. This position is responsible for establishing on-going processes for collecting and transforming data into strategic insights that support risk management, regulatory compliance, operational excellence, and governance reporting. This is a hi
Posted 8 days ago | Updated 4 hours ago

Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, Inc.

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Remote or Foster City, California, USA

Full-time

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro
Posted 23 days ago | Updated 4 hours ago

Sr. Manager, SAP CGTO Solutions Architect

Gilead Sciences, Inc.

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Remote or Santa Monica, California, USA

Full-time

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro
Posted 59 days ago | Updated 4 hours ago

Kinaxis Rapid Response Consultant

NexInfo Solutions, Inc.

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Remote or Foster City, California, USA

Contract, Third Party

Job Title: Kinaxis Rapid Response Consultant Location: Remote Job Type: Contract Job Summary: We are looking for a skilled Kinaxis Rapid Response Consultant to join our supply chain planning team. The ideal candidate will have hands-on experience with Kinaxis Rapid Response platform, and a strong understanding of supply chain processes including demand planning, supply planning, and scenario modeling.Key Responsibilities: Configure, develop, and deploy solutions using Kinaxis Rapid ResponseCol
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Posted 60+ days ago | Updated 2 days ago

Techno functional consultant TMS (Manhattan)

Echo IT Solutions, Inc.

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North Chicago, Illinois, USA

Contract

Job Title: Techno-functional consultant TMS (Manhattan preferred)Job Duration: ContractLocation: Abbott Park, Illinois, United StatesJob Description:Enterprise Req Skillswarehouse management system (WMS), transportation management (TMS), SAP ERP Top Skills Details Bachelor s degree required in computer science, supply chain management, or a related field. 8+ years of IT experience, with 4+ years focused on warehousing and transportation or related roles. Strong technical expertise in TMS (e.g.,
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Posted 6 days ago | Updated 4 days ago

Pharmacovigilance Business Analyst

Cygnus Professionals

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Remote

Full-time

Position Title: Pharmacovigilance Business AnalystLocation: Remote Duration: 12 plus months contract or Fulltime Requirements: Bachelor's degree in Statistics, Mathematics, Computer Science, Life Sciences or a related field.Minimum 10+ years of Business Analyst experience is required.Clinical Trial domain expertise, including Study Execution, Site Monitoring, Data Management, and Patient Safety.Exposure to Pharmacovigilance, and Quality and Compliance processes preferred.Experience with SQL and
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Posted 17 days ago

SAP Program Manager/Director

Dynamic Enterprise Solutions Inc

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North Chicago, Illinois, USA

Third Party, Contract

Detailed Job Description: The Sr. SAP Program Manager/IT Functional Lead will help coordinate with the functional and technical teams on multiple IT initiatives (Archiving and SAP Hardware upgrade) in the Abbott Business solutions and services group. The functional lead will be responsible for coordinating with the ERP application teams (Functional, Basis and Database), infrastructure teams (OS, Storage and Networking) and external vendors on the testing efforts across the landscape and ensuring
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Posted 10 days ago

IT Enterprise Architect with Life Science Experience

K Source Inc

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Remote

Third Party, Contract

Hi , This is Sagar from KSource Inc. We have an excellent job opportunity for you below is the JD please have a look. Job Title: IT Enterprise Architect with Life Science Experience Location: Boston, MA (Remote) Duration: 12+ months Job Description: The IT Enterprise Architect is a key role within Gates MRI IT, combing a blend of deep technical and architectural expertise with industry foresight, and strategic thinking. This position is essential for crafting a cohesive IT architecture that sup
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Posted 9 days ago

Lead Data Engineer / Lead Data Architect

Bossini Technologies

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Remote

Contract

Job Title: Lead Data Engineer / Lead Data ArchitectLocation: Remote (Preference for US-based candidates)Start Date: ASAP Must have 12+ years of overall IT exp. No OPT or CPT candidates H1B Transfers are encouraged to apply Must be authorized to work in the U.S. without sponsorship (unless H-1B transfer) Job Summary:We are seeking a highly skilled Lead Data Engineer / Lead Data Architect with strong experience in Python and Databricks, preferably with a background in pharmaceuticals or supply cha
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Posted 20 days ago

IRT Auditor

I.T. Solutions

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Remote

Contract

Role: IRT Auditor Location: Remote Type: Contract Length: 6 months Position Summary: We are seeking an experienced Oncology QA Auditor with a strong background in clinical quality assurance and a solid understanding of AI-driven technologies used in clinical trials. This role is essential to ensuring compliance across oncology programs that leverage artificial intelligence and machine learning (AI/ML) tools for clinical decision support, trial optimization, and real-world data interpretation.
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Posted 1 day ago

Veeva Promomats Technical Lead - 100% remote

MSquare Systems Inc.

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Remote

Third Party, Contract

We are seeking a seasoned Veeva PromoMats Technical Lead to oversee a high-impact migration project within the life sciences domain, transitioning digital content, metadata, and workflows from legacy systems or DAM platforms into Veeva Vault PromoMats. This role is responsible for leading the technical design, validation, and execution of the migration while ensuring regulatory compliance, content integrity, and operational continuity for commercial and medical review teams. Key Responsibilities
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Posted 60+ days ago | Updated 17 days ago

SAP EWM Consultant

Genius Business Solutions

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Remote

Contract, Third Party

Are you a passionate IT trailblazer a growth focused, problem solver who takes full ownership of your work, wants to collaborate & co-create with fellow IT experts, innovate, learn new skills, create new solutions & drive your career to the pinnacle of your potential? If so, you will love working with our Sales Team we are constantly innovating to create breakthrough solutions for our client s growth through a vibrant, fun team culture. Read on below to learn more Featured in CNBC, Digital Journ
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Posted 60+ days ago | Updated 10 days ago