21 CFR Part 11 jobs in Arizona

Oro Valley, Arizona

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Today

Title of Position: Technical Writer - Assay Development Location: Oro Valley, AZ (Onsite) Contract Length: 1 YEAR Pay Rate: $27.00 Job details: The primary responsibility of this position is to act as the Technical Writer on project teams, attend meetings, and update the supervisor. Involved in the creation, review, revision and approval of documentation and labeling for COMPANY products. SKILLS, EXPERIENCE & EDUCATION 3-5 years of direct documentation experience in medical device, software,

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Contract

USD 27.00 per hour

Technical Writer - Assay Development

Tucson, Arizona

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Today

Software Guidance & Assistance, Inc., (SGA), is searching for a Technical Writer - Assay Development for a contract assignment with one of our premier Pharmaceutical services clients in Tucson, AZ. Responsibilities : The primary responsibility of this position is to act as the Technical Writer on project teams, attend meetings, and update the supervisor. Involved in the creation, review, revision and approval of documentation and labeling for the firm's Tissue Diagnostics products. Required

Contract

USD 27.00 - 27.00 per hour

Sr. Regulatory Specialist SaMD / 510(k) / Medical Device | Contract | Remote

Remote

•

Yesterday

Sr. Regulatory Specialist SaMD / 510(k) / Medical Device Location: Remote - (Philadelphia, PA must work in EST time zone) Duration: Long Term Contract About the Role:We are seeking a Senior Regulatory Specialist with deep expertise in Software as a Medical Device (SaMD) and 510(k) submissions to support regulatory strategy and compliance for next-generation digital health and AI-enabled medical products.This role will partner closely with cross-functional teams (R&D, Quality, and Clinical) to en

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Contract

Depends on Experience

Immediate Job Hire : Veeva QMS QA @ Remote - Contract

Phoenix, Arizona

•

Yesterday

Job Title Veeva QMS QA Location Remote Duration 12+ Months Job Description: 6 8 years of experience in software testing, with minimum 5 years in Veeva Vault QMS testing Strong knowledge of life sciences quality processes (GxP, CSV, 21 CFR Part 11 compliance) Hands-on experience in functional, integration, regression, and UAT testing Proficiency in preparing validation documentation (test scripts, execution logs, traceability matrix) Experience with test management tools (ALM, Jira, etc.) Excel

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Contract, Third Party

$55

TIBCO Spotfire Developer

Remote

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3d ago

Title: TIBCO Spotfire Developer (Life Sciences Domain)Location: Remote - New JerseyEmployment Type: Contract Were looking for an experienced TIBCO Spotfire Developer with strong hands-on expertise in data visualization, analytics, and integration within the Life Sciences or Pharmaceutical domain. The ideal candidate will have experience developing interactive dashboards, integrating multiple data sources, and ensuring compliance with GxP and 21 CFR Part 11 standards. Key Skills:Spotfire, IronPyt

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Part-time, Third Party

Depends on Experience

LIMS Consultant

Remote

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2d ago

We are seeking a LIMS Specialist to manage, configure, and support our Laboratory Information Management System (LIMS). The role ensures smooth lab operations, data integrity, and regulatory compliance across all testing workflows. Key Responsibilities: Configure and maintain LIMS master data, workflows, and user access.Support implementation, validation (IQ/OQ/PQ), and system upgrades.Troubleshoot issues and coordinate with IT/vendors for resolution.Ensure compliance with GxP, 21 CFR Part 11, a

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Third Party, Contract

$60 - $70

Senior CSV Engineer

Remote or Massachusetts

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Today

Job Description: We are looking for a Senior Computer System Validation (CSV) Engineer to perform validation of computerized systems associated with Client's facilities, utilities, and equipment for the qc lab validation project. This role will focus on EMS, Client, and laboratory informatics/software platforms (e.g., HPLC/qPCR control software, Sicknotes, Blue Mountain), ensuring compliance with 21 CFR Part 11, Annex 11, and data integrity requirements. The CSV Engineer will obtain documentatio

Full-time

Empower CDS Administrator

Remote

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3d ago

Empower CDS Administrator Direct-Hire / FTE with WinWire REMOTE / Work From Home We are seeking an experienced professional to manage and support Waters Empower Chromatography Data System (CDS), oversee laboratory instrument integration, perform troubleshooting, and ensure system compliance with GxP and 21 CFR Part 11 regulatory requirements. The role also involves Computer System Validation (CSV), administration, and continuous improvement of laboratory informatics systems. Skills/Experience 3

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Full-time

Depends on Experience

Validation/Test Lead & Testers Regulated Systems (Veeva / SQM / QRM)

Remote

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Today

Job Title: Validation/Test Lead & Testers Regulated Systems (Veeva / SQM / QRM) Position Summary We are seeking experienced Validation/Test professionals-including a Validation/Test Lead and multiple Testers-to support a large-scale Veeva Quality implementation within a regulated (GxP) environment. The ideal candidates will have hands-on experience with Computer System Validation (CSV) processes, creation and execution of regulated validation deliverables, and a strong understanding of Suppli

Contract, Third Party

Project Manager Regulated Systems (Veeva Implementation)

Remote

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Today

Job Title: Project Manager Regulated Systems (Veeva Implementation) Position Summary We are seeking an experienced Project Manager with a strong background in regulated systems and vendor/IT coordination to lead the implementation and enhancement of Veeva applications (Vault QMS, RIM, QualityDocs, etc.). The ideal candidate will have demonstrated success managing projects in GxP-regulated environments, ensuring compliance, alignment with business objectives, and timely delivery of system soluti

Contract, Third Party

TIBCO Spotfire Developer

Remote

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Today

Solution IT Inc. is looking for TIBCO Spotfire Developer for one of its clients in Remote Job Title: TIBCO Spotfire Developer Summary We are seeking an experienced TIBCO Spotfire Developer with hands-on expertise in developing advanced analytics and visualization solutions for Life Sciences clients, particularly in Pharma R&D, Clinical, Regulatory, or Commercial data environments. The ideal candidate will be responsible for designing and implementing interactive dashboards, integrating data f

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Full-time, Contract, Third Party

R&D Business Systems Lead (BSA/PM) with Life Sciences -GxP Expereince

Remote

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30+d ago

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: R&D Business Systems Lead (BSA/PM) Location: Cambridge, MA (Remote) Duration: 12+ months Qualifications & Experience Required: 8+ years of combined experience in Life Sciences IT, including:Minimum 4 years in a GxP-regulated system administrator or support capacity.Minimum 4 years in project management, delivering cross-functional systems in R&D or Clinical domains.Str

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Contract

Depends on Experience

Clinical Domain SME || NC

Remote or Hybrid in Cary, North Carolina

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Yesterday

Job Title: Clinical Domain SME Life Sciences ConsultingLocation: NC Position SummaryClinical Domain Subject Matter Expert (SME) to lead strategic transformation initiatives across the life sciences ecosystem. This senior-level role demands deep expertise in clinical development spanning pharmaceuticals, biotech, medical devices, CROs, and SMOs and combines functional leadership with digital innovation, automation, analytics, and AI/GenAI capabilities. The SME will collaborate with executive and

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Contract, Third Party

Depends on Experience

Organizational Change Management (OCM)

Remote

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Today

Job Title: OCM / Training Lead & Trainers Regulated Systems (Veeva Quality Transformation) Position Summary We are seeking an experienced Organizational Change Management (OCM) / Training Lead and supporting Trainers to drive the change, communication, and learning strategy for a large-scale Veeva Quality transformation program. The OCM/Training team will play a critical role in ensuring business readiness, user adoption, and sustained process excellence across global functions. The ideal can

Contract, Third Party

Senior Staff Software Advance Quality Engineer (REMOTE)

Remote or Portage, Michigan

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Today

Work Flexibility: Remote or Hybrid or Onsite Senior Staff, Software Quality Assurance Engineer - Remote Stryker is seeking a Senior Staff Software Quality Assurance Engineer to support our Digital Robotics and Enabling Technologies business by driving quality processes. In this role, you will partner with R&D software development teams to guide them through internal quality system processes and ensure compliance with internal procedures and regulatory standards (e.g SOC 2, ISO, FDA and HIPAA)

Full-time

USD 115,600.00 - 245,800.00 per year

CSV and Validation Engineer

Remote or New Jersey

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Today

Job Description: We are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role owns risk-based validation planning and execution aligned to EMA Annex 11 and 21 CFR Part 11, authors audit-ready documentation, and partners with QA/IT/Lab to transition systems to standardized SOPs. Responsibilities: Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5. Validate instrument

Full-time

Application Analyst IV

Remote

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4d ago

Immediate need for a talented Application Analyst IV. This is a 12 months contract opportunity with long-term potential and is located in U.S(Remote). Please review the job description below and contact me ASAP if you are interested. Job ID:25-90333 Pay Range: $60 - $70/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location). Key Responsibilities: The ideal candidate will have strong progr

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Contract

$60 - $70

Controls Engineer (DeltaV)

Remote

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Today

Title: Controls Engineer (DeltaV) Location : Remote - but must be in the Kalamazoo, MI area Target Start Date : ASAP Type: Direct Hire Salary : $120-160K (DOE) plus uncapped bonus Our client, a Top 5 systems integrator for automation & controls systems with over 40 years of experience, is seeking an experienced Controls Engineer to design, configure, and implement Emerson DeltaV automation solutions, primarily for life sciences and other process manufacturing industries. This role involves deliv

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Full-time

USD 120,000.00 - 160,000.00 per year

Systems Administrator

Remote or Tennessee

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Today

It's More Than a Career, It's a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives

Full-time

Senior Process Engineer

Chandler, Arizona

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Today

Requisition ID: 289281 Relocation Authorized: National - Family Telework Type: Part-Time Telework Work Location: Chandler, AZ, Houston, TX Extraordinary teams building inspiring projects: Since 1898, we have helped customers complete more than 25,000 projects in 160 countries on all seven continents that have created jobs, grown economies, improved the resiliency of the world's infrastructure, increased access to energy, resources, and vital services, and made the world a safer, cleaner place.

Full-time

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21 CFR Part 11 jobs in Arizona, USA