21 CFR Part 11 jobs in California

Hybrid in San Francisco, California

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5d ago

Job Title: GxP Project Manager Location: Bay Area, CA Duration: 6+ months with possible of extension Required Qualifications Bachelor's degree in Engineering, Computer Science, Life Sciences, Pharmacy, Biotechnology, or related field.8+ years of Project Management experience within the Pharmaceutical or Biotechnology industry.5+ years managing GxP-regulated projects.Strong understanding of GMP, GxP, GAMP 5, FDA regulations, and 21 CFR Part 11.Experience managing Computer System Validation (CSV)

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Third Party, Contract

$80 - $90

CMO Digital Liaison & Data Steward

Remote

•

Today

Business Analyst / Digital Steward CMO Connections Role Overview We are seeking a technically grounded Business Analyst / Digital Steward to support digital connections with external Contract Manufacturing Organizations (CMOs). This person will help own the digital engagement with external manufacturing partners end to end from partner onboarding and tech transfer through commercialization and long-term sustainment of inline products. The role operates across a matrixed portfolio of strategic CM

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Contract

Depends on Experience

Senior QC Technician

Oceanside, California

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2d ago

Description: What you will do Create automated laboratory workflows and support development of laboratory recipeswithin the Biovia software system. Collaborate with business stakeholders to gather feedback and propose new functionalities Report defects, test new software features, and support system improvements Design and enhance reporting functionalities and interfaces within laboratory systems Work with end users to design and optimize complex workflows and processes Prepare and maintai

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Contract, Third Party

$28 - $35

Clinical Project Manager with RBQM, Veeva, CTMS, eTMF, EDC

Remote

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12d ago

Title: Clinical Project Manager with RBQM & Veeva Foster City, CA or Remote for people who can travel for meetings Experience Range: 10- max 22 years Writeup Skills PM with BA background and experience 6+ years of proven expertise in theclinical domain and operations, including hands-on experience with systems likeCTMS, eTMF, RBQM, and EDC. 8+ years of experience analyzing requirements, documenting findings, and ensuring effective communication and clarification with stakeholders. 6+ years of

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Full-time

Depends on Experience

Pharma Project manager

Hybrid in California City, California

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11d ago

Hi Job Title: Pharma Project Manager (No IT PM ) Location: California Duration : Long Term Contract Job Summary: We are seeking an experienced GxP Project Manager to lead and manage cross-functional GxP initiatives supporting pharmaceutical manufacturing, The ideal candidate will have strong experience delivering GxP-compliant projects within regulated pharmaceutical or biotechnology environments while ensuring compliance with FDA regulations, GMP, GAMP 5, and 21 CFR Part 11. Rajneesh Sing

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Contract

80 - 90

SAP BRH Functional / Support Lead

Remote

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Today

Job Summary: Seeking a Senior SAP Batch Release Hub (BRH) Functional/Support Lead with strong SAP BRH and S/4HANA QM expertise to support implementation, production sustainment, hyper care, and go-live activities in a regulated Life Sciences environment. Key Responsibilities Lead SAP BRH implementation, design, and production support. Handle P1/P2 incidents, RCA, defect resolution, integration troubleshooting, and hypercare. Support S/4HANA QM, including batch management, inspection lots, usage

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Contract

Depends on Experience

Mendix Platform Architect

Remote

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2d ago

Mendix Platform Developer/Architect|| Location Jacksonville, FL Remote || Employment type - contract Job Description: 10 years of software development experience. 5 years of Mendix development experience Experience serving as a solution architect or technical lead. Experience delivering enterprise-scale applications. Technical Skills Mendix Platform Architecture Mendix Studio Pro Microflows and Nanoflows Domain Modeling XPath and OQL Java Actions REST and SOAP APIS SQL Databases Azure

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Third Party, Contract

$65 - $70

Senior PLM Windchill Solution Architect

Remote

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4d ago

Position OverviewWe are looking for aSenior PLM Windchill Solution Architectto lead a strategic, customer-facing PLM engagement for a leadingMedical Device / Life Sciences organization.The ideal candidate will be a senior techno-functional architect with strongPTC Windchill PLMexpertise and experience owning end-to-end architecture, technical governance, integrations, migration, validation, AMS, and customer stakeholder management.Key ResponsibilitiesLead end-to-endPTC Windchill PLM solution arc

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Contract

80 - 90

Project Manager / Business Analyst

Santa Clara, California

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19d ago

Project Manager / Business Analyst Full-Time / Direct-Hire Foster City, CA 94404 - Onsite Salary Market-based on exp. We are seeking a Project Manager with Business Analyst experience in requirement gathering, documentation, and stakeholder engagement within the clinical domain. The ideal candidate will have strong expertise in analyzing and translating business needs into BRDs, user stories, and acceptance criteria, while collaborating closely with development, QA/UAT, and project management te

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Full-time

Depends on Experience

Sr Track Wise Consultant

Hybrid in Sunnyvale, California

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3d ago

Job Title : Sr Track Wise Consultant Location : Sunnyvale, CA (Hybrid) Duration : 1 Year Job Description: Top Skills TrackWise ConfigurationTrackWise Web Service DevelopmentTrackWise Crystal Reports DevelopmentStrong knowledge and experience in Java programmingDetailed Job Description Position Overview Person will be responsible for identifying, developing and implementing software solutions.This will include working with process owners to identify continuous improvement opportunities and develo

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Full-time

$75 - $90

Automation QA Engineer – Genomics / Bioinformatics

San Diego, California

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Today

We are hiring an Automation QA Engineer to test software systems used in genomics and life sciences workflows. This is a quality engineering role, not a bioinformatics pipeline development role: you will design, build, and execute automated and manual test coverage for platforms that process genomic and laboratory data, and you will validate that results align with real wet lab and dry lab processes. Strong Python-based test automation skills are essential; genomics/BioE domain knowledge is what

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Contract, Third Party

Depends on Experience

Senior Technical Business Analyst

Remote

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6d ago

DescriptionJob Title: Senior Healthcare Business Analyst Type: Part Time Experience Level: Senior Seeking a highly skilled and experienced Senior Business Analyst responsible for bridging the gap between business objectives and technology solutions, ensuring that our projects align with organizational goals and deliver maximum value. You will utilize your expertise in business analysis and data-driven decision-making to identify opportunities for improvement and drive successful project outcomes

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Part-time

Depends on Experience

Automation QA Engineer

Hybrid in San Diego, California

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Today

Role- Automation QA Engineer Genomics / Bioinformatics Location San Diego CA (Onsite) Contract Job Description:- We are hiring an Automation QA Engineer to test software systems used in genomics and life sciences workflows. This is a quality engineering role, not a bioinformatics pipeline development role: you will design, build, and execute automated and manual test coverage for platforms that process genomic and laboratory data, and you will validate that results align with real wet lab and dr

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Third Party, Contract

Depends on Experience

Director Data AI & Analytics

Irvine, California

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Today

Position Overview Position Description We are hiring a Director Data, AI and Analytics. The Director Data, AI and Analytics will own the strategy, platforms, operating model, and outcomes for Data, AI, and Analytics across three FUJIFILM life-sciences businesses. In highly regulated GxP environments, deliver a trusted data backbone, governed self-service analytics, advanced analytics, bioinformatics pipelines, and agentic AI-meeting 21 CFR Part 11/EU Annex 11, ALCOA+, and CSV/CSA expectations.

Full-time

USD 154,565.00 - 216,100.00 per year

GxP Project Manager

Hybrid in Foster City, California

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Today

Role Summary The driving force behind constant business growth is the presence of skilled and dedicated project managers. The ideal candidate will have pharma experience with GxP Technical Development or Pharma Biotech experience with strong work plan development and progress oversight skills. He/She will be expected to oversee the planning and implementation of an entire project through budgeting, assessing team members, engage with suppliers and plan the project release. Their duties include s

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Contract, Third Party

$80 - $90

Sr SampleManager Implementation Engineer

Remote or Indiana

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Senior SampleManager LIMS Implementation Engineer How will you make an impact? As a Senior SampleManager LIMS Implementation Engineer, you will be a technical expert responsible for the configuration, implementation, integration, and deployment of Thermo Scientific SampleManager LIMS solutions. This role is highly hands-on and focused on translating defined laboratory processes and solution designs into robus

Full-time

USD 93,800.00 - 140,675.00 per year

Project Manager- Life science industry

Remote

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14d ago

Job Title: Project ManagerLife science industryLocation: Foster City, CA (Fully remote)Duration: FTEEducational Qualification*Any Bachelor''s DegreeExperience Range10 YearsTagline/Tech Stack Snapshot -PM with BA background and experienceRole Summary - (To be filled by Practice /DO)We are seeking a PM and Business Analyst with requirements gathering, documentation, and stakeholder engagement within the clinical domain. The ideal candidate will have strong expertise in analyzing and translating bu

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Full-time, Third Party

0 - 0

SAS Programmer

San Francisco, California

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Today

Responsibilities: Develop, maintain, and execute SAS programs to support external data transfers, including validation against vendor transfer specifications. Generate and maintain Data Review Listings (DRLs) and Study Health Metrics (SHMs) in accordance with study timelines. Perform peer review of DRLs and data reconciliation reports. Monitor automated job logs and resolve issues as needed. Retrieve and post external vendor data using sFTP/FTP clients and vendor portals. Collaborate with data m

Full-time

Bioinformatics Pipeline Junior Test Engineer

San Diego, California

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Today

Requirements: B.S. Degree in Computational Biology, Computer Science, or field as outlined in the essential duties. Familiarity with the development of bioinformatics pipelines within Next Generation Sequencing and PCR applications. Familiarity with production software development lifecycle. Familiarity with best practices for software development (such as Git, agile, code reviews, CI/CD). bility to effectively communicate software system designs. Excellent communication skills (both written and

Full-time

Senior Application Developer, Business Systems

Irvine, California

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Today

Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) business's AI, Product and Platforms organization is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It is our driving force to help patients

Full-time

USD 108,000.00 - 153,000.00 per year

21 CFR Part 11 jobs in California, USA