GXP Jobs in California

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Senior Director, Head of Research Systems Engineering

Johnson & Johnson

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Remote or Pennsylvania, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 7 days ago | Updated moments ago

Lab Instrumentation Engineer

Novartis

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Carlsbad, California, USA

Full-time

Job Description Summary Responsible for installation, maintenance and calibration of high-end analytical equipment. Perform tasks accurately and on schedule. Know and follow all safety procedures and be able to respond appropriately. Job Description Major accountabilities: Works in a GMP/Google Cloud Platform/GLP/CLIA regulated environment and is responsible for following all applicable regulationsWork independently and/or with minimal supervision to conduct laboratory instrumentation service
Posted 5 days ago | Updated moments ago

CSV/ CSA Engineer

Katalyst Healthcares and Lifesciences

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San Francisco, California, USA

Full-time

Job Description: The CSA Engineer will be responsible for ensuring that all computer systems, software applications, and related processes comply with industry standards and regulatory requirements, especially in regulated environments such as pharmaceutical, biotech, and healthcare sectors. Responsibilities: 10 Plus Years of experience in Computer System Assurance (CSA) or Computer System Validation (CSV) in regulated industries such as pharmaceuticals, medical devices, or biotechnology. Stron
Posted 60+ days ago | Updated moments ago

RWE Data Scientist II

Katalyst Healthcares and Lifesciences

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South San Francisco, California, 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 moments 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 36 days ago | Updated moments ago

Manager, IT/Senior Systems Analyst

Thermo Fisher Scientific

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Massachusetts, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Manager, IT/Senior Systems Analyst HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Support Thermo Fisher's integration of Tracelink (Track and Trace Solution) and Thermo Fisher's downstream partners to ensure Thermo Fisher is compliant with Serialization and Track and Trace requirements and detailing the technical
Posted 28 days ago | Updated moments ago

Sr. Data Engineer with Medical Imaging

ADDSOURCE

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San Francisco, California, USA

Third Party

Title: Sr. Data Engineer with Medical Imaging Location: San Francisco, CA (4 days onsite every week) This position is for a Sr Data engineer to join this global team of Imaging data managers to realize the product vision and value Mandatory Skills: Medical Imaging, Data engineering, Python Key Responsibilities: Imaging Data Pipeline delivery : Design, implement and maintain automated pipelines for onboarding, verifying, transforming and curating biomedical imaging data from clinical trials and
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Posted 14 days ago | Updated 13 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 moments ago

Principal Software Engineer

Amgen Inc

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Remote or Thousand Oaks, California, USA

Full-time

Career Category Information Systems Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of pati
Posted 8 days ago | Updated moments ago

Senior Manager, Data Analytics

Quest Diagnostics Inc.

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Remote or Wood Dale, Illinois, USA

Full-time

Overview 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 highly vi
Posted 22 days ago | Updated 3 days ago

Sr Associate Scientist, Data Analytics -Cell Therapy

Gilead Sciences, Inc.

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Santa Monica, California, USA

Full-time

We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great l
Posted 14 days ago | Updated moments ago

IT Engineering Specialist III

HAYS

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San Francisco, California, USA

Contract

IT Engineering Specialist - Contract - San Francisco, CA - $73.43 - $73.43/hr. The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position. Applicants must be legally authorized to work in the United States. Visa sponsorship is not available. Our c
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Posted 52 days ago | Updated 9 hours ago

IT Systems Analyst II - Inari Medical

Stryker

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Irvine, California, USA

Full-time

Work Flexibility: Hybrid Summary Objective The Systems Analyst II role leads the administration, enhancement and support of key enterprise and business applications and leads/contributes to complex system projects that involve multiple stakeholders, systems, and delivers solutions that meet business objectives in alignment with the strategic vision and objectives of the organization. Essential Functions & Responsibilities Serve as a Lead Admin for one or more enterprise/business systems; respo
Posted 25 days ago | Updated moments 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 14 days ago | Updated moments ago

Software Developer for Lab Informatics/ Life Science Platforms - San Diego

Accenture LLP

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San Diego, California, USA

Full-time

A Software Developer for Lab Informatics/ Life Science Platforms Location: Sand Diego, resource will be 100% onsite at client, acting as the interface between the site's stakeholders and the Accenture global support team. This resource needs to have strong communication / client facing skills and will serve as main point of contact and act in a liaison capacity to facilitate problem resolution, communicating between IT teams and other departments as required. This resource needs to have flexibil
Posted 40 days ago | Updated moments 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 50 days ago | Updated moments ago

Technical Writer

Ab Ovo Inc

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Santa Monica, California, USA

Contract

One of our direct Pharmaceutical client is looking to hire Technical Writer at Santa Monica, CA (Hybrid). The ideal candidate will have a strong background in healthcare regulations, excellent writing skills, and the ability to produce clear and accurate documentation. Key Responsibilities: Develop, write, and maintain documentation for PHI, GXP guidelines, and healthcare quality standards.Collaborate with healthcare professionals, regulatory experts, and other stakeholders to gather informatio
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Posted 3 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 8 days ago

Laboratory Information Management System (LIMS) /ELN Consultant, MN/REMOTE - Direct Client

Javen Technologies, Inc

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Remote

Contract, Third Party

Javen Technologies Direct Client is looking for Laboratory Information Management System (LIMS)/Electronic Lab Notebook (ELN) Consultant in Maplewood MN. 100% REMOTE opportunity. If interested, please reach me at / - Gowri. Domain Knowledge: Experience with LIMS (Laboratory Information Management Systems) preferably LabVantage Understanding of clinical, research, or diagnostic lab workflows Knowledge of regulatory requirements (GxP, FDA 21 CFR Part 11) Familiarity with lab instruments, integra
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Posted 1 day ago

Lead IT Validation Consultant

Amaze Systems Inc

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New York, USA

Contract, Third Party

Lead IT Validation Consultant Remote Notes : Prior experience in CROs, clinical research organizations, or pharmaceutical/biotech companies. Knowledge of laboratory processes such as PK, TK, and biomarker studies. Experience with integration of LIMS with other lab or enterprise systems (e.g., CDS, ELN, CTMS).Validation or QA certifications a plus. JD: We are seeking an experienced IT Validation Consultant to lead and support the validation of Laboratory Information Management System (LIMS) used
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Posted 3 days ago | Updated 13 hours ago