gxp Jobs in california

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Technical Writer (GxP with Healthcare/Pharma/Lifescience domain)

Ab Ovo Inc

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Santa Monica, California, USA

Contract

One of our direct Pharmaceutical client is looking to hire Technical Writer (GxP with Healthcare/Pharma/LifeScience domain) - at Santa Monica, CA (Hybrid). Seeking a skilled Technical Writer to create and maintain documentation related to Protected Health Information (PHI), Good Practice (GXP) guidelines, and healthcare quality standards. The ideal candidate will have a strong background in healthcare regulations, excellent writing skills, and the ability to produce clear and accurate documenta
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Posted 12 days ago | Updated 7 days ago

Senior Pharma GxP Project Manager with a strong background in SAP S/4 HANA validation

Pioneer Corporate Services Inc

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Foster City, California, USA

Third Party, Contract

Job Title: Senior Pharma GxP Project ManagerLocation: Hybrid Foster City, CA (Locals or nearby states preferred)Duration: 12 Months Job Description:We are seeking a Senior GxP Project Manager with a strong background in SAP S/4 HANA validation and Life Sciences industries. The role demands excellent stakeholder and change management skills, hands-on validation expertise, and solid project leadership. Must-Have Skills: 15 20 years of overall experience 8+ years in Computer System Validation (CSV)
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Posted 6 days ago | Updated 6 days ago

GxP Business Analyst/Project Manager

Eliassen Group

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Anywhere, US

Contract

Description: **Remote** Our Biotechnology client is looking for a GxP Business Analyst/Project Manager to come on for a long-term contract. This person is needed to help "keep the lights on" with respect to legacy systems that are being used for submissions to meet regulatory requirements across the globe. Regulatory requirements are constantly evolving, and our client has to keep product documentation up to date in order to be in compliance and continue to do business in different countries
Posted 60+ days ago | Updated 7 hours ago

Technical Writer

SPECTRAFORCE TECHNOLOGIES Inc.

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Santa Monica, California, USA

Contract

Technical Writer Santa Monica, CA 90404 (Onsite) 6 Months Job Summary: We are seeking a skilled Technical Writer to create and maintain documentation related to Protected Health Information (PHI), Good Practice (GXP) guidelines, and healthcare quality standards. 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,
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Posted 12 days ago

SAP Project Manager-Bio-Pharma

NexInfo Solutions, Inc.

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Remote

Contract, Third Party

About Nexinfo: NexInfo is a consulting firm focused on improving business processes and automation in the Supply Chain and Product Lifecycle Management sectors. They offer services in business process design, software implementations, managed services, staff augmentation, and SaaS solutions. The company aims to help businesses across industries achieve their goals through industry best practices, lean process design, and advanced software solutions. Their ERP-related services address challenges
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Posted 21 hours ago

Lead Agile Coach

Intento Analytics LLC

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Remote

Contract

Skills required: Agile, Lead, Certification , GXP, compliance and Audit , Jira and Pharma industry Required Qualifications SAFe Certified professional with deep expertise in Apptio TargetProcess, Jira, and scaled agile delivery frameworks . Demonstrated knowledge of GxP-regulated projects in the pharmaceutical industry, ensuring compliance and audit readiness during Agile delivery. Skilled in the development and management of Objectives and Key Results (OKRs) to align program delivery with st
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Posted moments ago

Lead Agile Coach

Intento Analytics LLC

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Remote

Contract

Job Title : Lead Agile Coach Location: 100% Remote Work Authorization: (H1B/ EAD/L2 EAD/EAD/OPT) Skills required: Agile, Lead, Certification , GXP, Compliance and Audit , Jira and Pharma industry Required Qualifications SAFe Certified professional with deep expertise in Apptio TargetProcess, Jira, and scaled agile delivery frameworks . Demonstrated knowledge of GxP-regulated projects in the pharmaceutical industry, ensuring compliance and audit readiness during Agile delivery. Skilled in the d
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Posted 1 hour ago

Business Analyst

NTT DATA Americas, Inc

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Remote or Pittsburgh, Pennsylvania, USA

Contract

Company Overview: Req ID: 328701 NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. NTT DATA's Client is currently seeking a Cybersecurity Business Analyst to join their team in Pittsburgh, Pennsylvania (US-PA), United States (US). (REMOTE)Job Description: Experience Level: 7-9 years of relevant experience Role Overview: The Business Analyst (BA) wil
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Posted 5 days ago | Updated moments ago

Senior Business & Program Management Consultant (32660)

Myticas LLC

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Remote or Chicago, Illinois, USA

Contract

Senior Business & Program Management Consultant (GxP/Clinical) Location: Waukegan, IL (3 days onsite) Company: Myticas's direct client based in North Chicago, IL MUST Have: 8-10 years of Senior IT project experience: System Lifecycle (SLC) Expertise. GXP system experience required - GXP system implementation including custom development and validated systems. Portfolio / Program management experience. Clinical Systems Project financial management, and vendor management expertise. Description:
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Posted 4 hours ago

Veeva Presales Consultant

NexInfo Solutions, Inc.

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Remote

Contract

Title: Veeva Presales ConsultantLocation: Remote Client Engagement & SolutioningEngage with potential clients to understand their business challenges, current system landscape, and digital transformation needs.Lead discovery sessions to gather functional and technical requirements relevant to Veeva Vault solutions (e.g., Veeva CRM, Vault Quality Docs, RIM, eTMF, PromoMats, etc.).Articulate the value proposition of Veeva products and services in the context of customer-specific use cases.Content
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Posted 28 days ago | Updated 1 hour ago

LIMS - Laboratory Information Management Systems

Javen Technologies, Inc

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Remote

Contract, Third Party

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, integrations, and data flows Working with ELNs (Electronic Lab Notebooks) and lab automation Basic understanding of data security, validation, and integrity in lab system Skills: Business Analysis Skills: Requirements gathering and documentation Proce
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Posted 5 days ago | Updated 1 hour ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Santa Clara, California, USA

Full-time

Roles & Responsibilities: Software quality assurance or software validation. Preferably within the medical device industry. Strong knowledge of FDA 21 CFR Part 820, ISO 13485, IEC 62304. Experience in non-product software validation. Includes tools for development, testing, maintenance. Deep understanding of quality standards and regulatory requirements: FDA 21 CFR Part 820. ISO 13485. IEC 62304. Software quality assurance. Software validation. Non-product software tools (for testing
Posted 2 days ago | Updated 7 hours ago

Engineer III, Validation

Thermo Fisher Scientific

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Remote or Waltham, 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: Engineer , Validation HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Perform technical diagnosis of operational problems, repairs, and calibrations on a wide range of laboratory equipment to ensure that the equipment is operating to the customer's complete satisfaction and manufacture specifications; Perform techn
Posted 29 days ago | Updated 7 hours ago

LIMS and QC Applications Consultant

Expedite Technology Solutions

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Remote or Bridgewater, New Jersey, USA

Full-time, Contract

Solution Architecture and Design: Lead the design and development of LabVantage LIMS solutions tailored to business and laboratory needs. Develop system workflows, configurations, and integrations with other enterprise systems (e.g., S4 Hana ERP, MES, ELN, SDMS). Define data models, interface designs, and system configurations. Implementation and Deployment: Oversee installation, configuration, and validation of LabVantage LIMS applications. Develop and execute project plans, ensuring timely an
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Posted 60+ days ago | Updated moments ago

Global IT Compliance Sr Specialist

Thermo Fisher Scientific

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Pennsylvania, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing so
Posted 16 days ago | Updated 7 hours ago

Validation Engineer/CSV Engineer

Katalyst Healthcares and Lifesciences

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Walnut Creek, California, USA

Full-time

Job Description: 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 applicabil
Posted 7 hours ago

System Validation Engineer

Katalyst Healthcares and Lifesciences

•

Santa Clara, California, 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 11 days ago | Updated 7 hours ago

Medical Device & Regulations Engineer

Katalyst Healthcares and Lifesciences

•

Santa Clara, California, 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 applicabil
Posted 16 days ago | Updated 7 hours ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

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Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's
Posted 19 days ago | Updated 7 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 7 hours ago