GxP jobs

Technical Writer/Procedure Document Specialist IV - GxP (not GMP)

Plainsboro Township, New Jersey

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6d ago

Description: TOP SKILLS PER MGR: Pharma Industry ExperienceExperience w/GxP documentation required (not GMP)SOP Writing expertisePatient Safety knowledge/experience (HUGE PLUS) Job Summary We are seeking a skilled Technical Writer/Procedure Document Specialist to collaborate with colleagues, customers, and stakeholders on projects focused on process enhancement and continuous improvement within the CMR Strategic Operations, GxP Compliance & Technical Operations. This role will emphasize the de

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Contract

$72.23

GxP Test Lead

Hamptons at Boca Raton, Florida

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12d ago

Role: GxP Test Lead Location: Boca Raton, Florida, USA - onsite Hire Type: C2C, W2, 1099Visa : TN, E3 Mandatory Skills: Validation Testing, QMS, Hand on in ALM/Codebeamer, Life Science Domain.15+ years of software QA/testing experience, with at least 10+ years in regulated environments like life sciences, pharma, healthcare.Strong expertise in GxP compliance, CSV, and FDA 21 CFR Part 11 standards.Strong leadership, test planning, estimation, and cross-functional communication skills.Experience

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Full-time

$50 - $60

IT SOX GxP Analyst

Alameda, California

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4d ago

IT SOX GxP Analyst Alameda, CA (Onsite - no remote/hybrid) 6 Months Contract + Likely Extensions Job Description: Ability to manage and implement SAP-GRC components and frameworkCreate the product vision, customer persona identification, product framework for ITs compliance practices including the scopes of SOX and GxPOur client is a public biopharmaceutical company that is regulated by different governmental agencies. It is important that IT operates in a manner that is consistent, accurate, an

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Contract

$75 - $80

GxP Lab Computing Engineer

Boston, Massachusetts

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5d ago

GxP Lab Computing Engineer Location: Cambridge, MA (Onsite) Duration: 12 month MOI: Virtual Looking for candidates with EMPOWER experience The Lab Computing Engineer provides both consulting, analytical and technical laboratory services, including multivendor instrument, information technology as well as in-lab validation/compliance services when applicable. The individual will provide the consulting skills required to analyze customer needs and gaps to propose solutions for the desired state.

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Third Party, Contract

Depends on Experience

IT Lab Empower Support

Cambridge, Massachusetts

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4d ago

Hiring IT Lab Empower Support Engineers in Cambridge, MA The Lab Computing Engineer provides both consulting, analytical and technical laboratory services, including multivendor instruments, information technology as well as in-lab validation/compliance services when applicable. The individual will provide the consulting skills required to analyze customer needs and gaps to propose solutions for the desired state. He or she will work with business users and managers of customers in conjunction w

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Full-time

$40 - $45

LabVantage LIMS Developer

Remote

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22d ago

Roles & ResponsibilitiesPosition OverviewWe are seeking a highly skilled LabVantage LIMS Developer & Support Engineer responsible for delivering high quality LabVantage LIMS solutions, enhancements, and integrations while also providing functional and technical support to business users. This hybrid role combines hands-on development (70%) with application support and maintenance (30%) to ensure the smooth operation, customization, and continuous improvement of laboratory workflows within the La

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Full-time

110,000 - 115000

IT SOX Analyst

Alameda, California

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20d ago

IT SOX Analyst Alameda, CA (Onsite - no remote/hybrid) 6 Months Contract + Likely Extensions Job Description: Create the product vision, customer persona identification, product framework for IT's compliance practices including the scopes of SOX and GxPHighly focusing onSAP GRC Process evaluationOur client is a public biopharmaceutical company that is regulated by different governmental agencies. It is important that IT operates in a manner that is consistent, accurate, and high quality so that

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Contract

75 - 80

Technical Writer/Procedure Document Specialist IV [ From pharmaceutical Background]

Hybrid in Plainsboro Township, New Jersey

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Today

Job Posting Title - Technical Writer/Procedure Document Specialist IV Required - Education: Minimum of a BA or BS required; an advanced degree in a relevant field is desirable. Degree or professional certification in process design or change management is a plus.Minimum 7+ years of experience in the design and documentation of pharmaceutical business processes and change management required.Experience in process training development, delivery, and/or implementation is preferred, including the c

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Third Party, Contract

Depends on Experience

Technical Writer

Remote

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8d ago

Hello This is Prasad from Apex-2000.We have a job position for Technical Writer The End client is not mentioned Yet.The Implementing Company is Infosys.Contract based job.Remote role JD:Technical Writers life science GxP, regulatory experience If you're Interested, Please let me know Thanks & Regards. Prasad Zodage Resource Manager Apex-2000 Inc. Office Number: Plus One Seven zero three six six two zero two four six

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Contract

Depends on Experience

MES Validation Engineer - Hillsboro, OR

Hybrid in Hillsboro, Oregon

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Yesterday

Required Skills: The ideal candidate brings: Experience in Rockwell FactoryTalk PharmaSuite 5 years of experience as a Validation Professional; Proven experience in developing and executing validation protocols for computer systems Strong knowledge of regulatory requirements such as FDA, EMA, GxP, and industry standards related to system validation Ability to assess and mitigate risks associated with computer systems and ensure compliance with industry best practices A solid understanding of Com

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Contract

Depends on Experience

Lead Integration & Architecture

Wilson, North Carolina

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8d ago

Job Title: Lead Integration & Architecture (Onsite at Client Location) Location: Wilson, NC (100% Onsite) Employment Type: Contract About the RoleWe are seeking a highly skilled Lead Integration & Architecture for a Greenfield manufacturing facility project, who will be the site team liaison to between IT and business cross functional teams to ensure the quality delivery of 40+ digital capabilities for new site from architecture and integration execution & delivery perspective. This is a dual r

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Contract

$60+

Auditor

Chicago, Illinois

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Yesterday

Job Title: Auditor Consultant Location: Chicago, IL Type: Contract We are seeking an experienced Audit Lead with strong GxP.Lead and support GMP/GxP audits across regulated manufacturing environments.Coordinate effectively between auditors, quality teams, and project stakeholders.Ensure audit readiness by managing documentation, evidence collection, and compliance activities.Support internal, external, supplier, and regulatory inspection audits.Provide guidance to project teams on quality stan

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Contract, Third Party

Up to $60

Project Manager with LIMS Sample - Remote / Telecommute

Santa Clara, California

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4d ago

We are looking for Project Manager with LIMS Sample - Remote / Telecommute for our client in Santa Clara, CA Job Title: Project Manager with LIMS Sample - Remote / Telecommute Job Location: Santa Clara, CA Job Type: Contract Job Description: Pay Range: $63hr - $68hrManage the planning and Implementation of a Sample Manager application for the business.Manage the planning and implementation of ECG/Telemetry equipment and solutions at US and Prague clinics.Role Scope / Deliverables: Understand th

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Third Party, Contract

Depends on Experience

Technical Lead (COTS L3 Support) - Foster City, CA

Foster City, California

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Today

Our client seeks an Technical Lead (COTS L3 support for a Full Time project in Foster City, CA . Below is the detailed requirement Title: Technical Lead (COTS L3 support Location : Foster City, CA Duration: Full Time We are looking for a proactive and technically skilled **COTS Support Engineer** with 6+ years of experience supporting commercial off-the-shelf (COTS) applications in the **Life Sciences domain**. The ideal candidate will have a strong foundation in application support and a keen

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Full-time

$DOE

COTS Support

Foster City, California

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25d ago

Job Title: COTS Application SupportDuration: Long term contract/FTELocation: Foster City, CA Educational Qualification*Any Bachelor's DegreeExperience Range8+ yearsPrimary (Must have skills)* - To be Screened by TA Team6+ years of experience in **COTS application support**, preferably in life sciences or healthcare. 4+ years of experience Submission Publishing System (Lorenz), GFAP and Peripheral Systems/Software 4+ yrs of experience of ITIL processes and incident/change/problem management. 4+

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Third Party, Contract

Depends on Experience

Computer System Validation (CSV) Engineer

Remote

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Today

Position: CSV-QA / SQA EngineerLocation: Preferred Bay area candidate HybridBut open for REMOTE ONLY for 100% skill matching candidates Position Summary: Sr CSV-QA / SQA Engineer will work with the Natera Software Engineering team to ensure appropriatesoftware validation & lifecycle documentation is in place to support changes to Laboratory and Productsoftware systems. This role will provide value-added guidance throughout the software development lifecycle process. Primary Responsibilities: Pr

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Contract

Depends on Experience

SAP S/4 Hana PP Consultant

Remote

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Today

Title: SAP S/4 Hana PP ConsultantLocation: Remote Role (Occasional Travel to Bay Area, CA -all travelling expenses will be paid by the client) Client: Pharma domain Implement Infosys Visa: or USC Contract Base Expe: Minimum overall 10 to 12 years of experience required. Rate: Maximum $85/hr C2C Mandatory Skills: 2 projects in SAP S/4 Hana, SAP S/4 PP and Expertise in subcontracting, tolling, batch management, material movements, consumption tracking and intercompany supply flows. allocations and

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Contract

Depends on Experience

Salesforce Tech Lead/ Architect : Santa Monica, LA- Hybrid

Hybrid in Santa Monica, California

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4d ago

Title: Salesforce Tech Lead Location: Santa Monica, LA - Hybrid role JD: The Salesforce Tech Lead will be responsible for the tactical execution of the Salesforce platform s stability and enhancement phases. He will bridge the gap between high-level architectural designs and the actual development work, overseeing a team of developers to ensure that data integrations are and that the ProTrac-to-Tulip migration follows strict GxP coding standards. Act as the final gatekeeper for all code (Apex, L

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Contract

Depends on Experience

MES Validation Engineer

Hillsboro, Oregon

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5d ago

Title: Validation Engineer Location: Hillsboro, OR Payrate: $65-90/hour on W2 + Benefits As a member of our Manufacturing Execution System (MES) team, you will have the opportunity to bring state of the art automation technology to our site, optimizing our ability to serve patients efficiently. You will play a crucial role in supporting the multi-phase deployment of MES. As a Validation Engineer, you will own a dynamic range of responsibilities where you will have the chance to work collaborativ

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Contract

$64.01 - $96.99

HSE Application Support Specialist

Lebanon, Indiana

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13d ago

Job Overview We are seeking a skilled HSE Application Support Specialist to provide technical and functional support for SaaS-based HSE applications within a regulated pharmaceutical environment. The ideal candidate will have strong experience in managing enterprise applications, collaborating with vendors, and ensuring compliance with system qualification standards. Key Responsibilities Provide end-to-end support for HSE SaaS applications in an enterprise environment.Manage user requests, incid

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Third Party, Contract

Depends on Experience

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