FDA jobs in New Jersey

Remote

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7d ago

POSITION TITLE:Information Technology Specialist - FDA LOCATION:Remote CLEARANCE:Must be able to obtain aHigh-RiskPublic Trust COMPANY OVERVIEW At APV,weremore than a technology company werea mission-driven powerhouse transforming organizations through advanced technology and human ingenuity. Ourexpertisespans AI/ML, data architecture, low-code/no-code development, AgileDevSecOps, and cloud services, delivering scalable and meaningful solutions. In our Emerging Technology Lab, innovation drive

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Contract

Depends on Experience

Senior Android Developer

Remote

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6d ago

HiAssociate, Greetingsfor theday, We have a position as aSenior Android Engineerrole forRemote.Please find the job description below for this position. Role:Senior Android Engineer Location: Remote Duration: 24 Months Note: Healthcare or Medical Device experience is mandatory. Key Responsibilities: Triage and debug field issues reported by users of our Android applications. Analyze crash reports, logs, and other diagnostic data to identify the root cause of issues. Develop understanding of ex

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Contract

Depends on Experience

SAP QM Architect

Remote

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26d ago

SAP QM ArchitectThe SAP Quality Management (QM) Architect leads the design, implementation, and optimization of SAP QM solutions in a regulated medical device manufacturing environment. The role requires deep expertise in QM processes, strong cross-module integration skills, and hands-on experience across implementations, rollouts, and upgrades. The architect ensures quality processes meet FDA/ISO standards and seamlessly integrate with manufacturing, supply chain, and compliance systems. Respon

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Depends on Experience

Regulatory Specialist

Remote

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2d ago

Job Title:Regulatory Specialist Location:Rosemont, IL - Remote Duration: Long Term Contract Key Responsibilities: Provide strategic input and technical guidance on regulatory requirements to R&D project teams. Develop and implement regulatory strategies to facilitate the progress of US and Global programs and initiatives for the company. Evaluate regulations, establish framework, and design and implement science-based registration strategies for company products to ensure rapid, high-quality s

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Contract

Depends on Experience

Auditor

Remote or Chicago, Illinois

•

Today

Job Title: Quality Auditor Locations: Remote (50 - 60% Travel is expected anywhere in US but that will be sponsored) Duration: 6 months Contract Pay Range: $40 - $43/hr. Must Have's 8+ years of Quality Assurance and Quality Auditing experience within the medical device or pharmaceutical industry Extensive experience leading supplier/vendor audits from planning through final reporting Expert knowledge of FDA regulations (21 CFR Parts 210, 211, and 803), ISO 13485, and Quality Management Systems

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Full-time

$40.0000 - $43.0000

Validation Lead - Raritan, NJ(Hybrid)

Raritan, New Jersey

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4d ago

We are looking for a Validation Lead to join our team. Please review the job description below, and let us know if you are interested and available. If this opportunity matches your experience and career goals, we would love to discuss it more. Additionally, feel free to share your updated resume for consideration Role - Validation LeadLocation Raritan, NJ(Hybrid) Duration: Long Term Contract Rate: $70/HR on C2C Max Must Have - Computer System Validation experience M&A related Data Migration

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Contract, Third Party

60 - 70

Clinical Research Scientist III - (Director/Assoc. Director level)

Remote or Hybrid in Parsippany-Troy Hills, New Jersey

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10d ago

Acquires and utilizes knowledge of clinical trial design to develop specific study concept sheets and protocols. Participates in protocol review discussions concerning scientific and procedural aspects of study design. Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed with appropriate guidance and supervision. With supervision, contributes to the design and development of CRFs, Data Management Manuals and Da

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Third Party, Contract

$100 - $110

QA Test Engineer

Remote

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24d ago

Blu Omega is seeking a QA Test Engineer to support a federal program focused on data validation and workflow testing within the FDAs Regulated Product Submission (RPS) program. This role operates in a remote environment and is responsible for executing functional, integration, and data verification tests. The position requires experience supporting testing efforts in a mission-driven environment, with a focus on data accuracy, integrity, and consistency. Program Overview Program: FDA Regulated P

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Full-time

125,000 - 135,000

Clinical Information Specialist with Womens Health Clinical Practice (W2 ONLY)

Remote

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Today

Clinical Information Specialist / W2 ONLY / REMOTE / Contract Role About our Customer & Role: Our DIRECT customer, a global leader in Pharmaceutical industry is seeking an experienced Clinical Information Specialist with at least 5 years of experience, in Women s Health Clinical Practice. The Clinical Liaison acts as a liaison for healthcare providers, supporting the clinical use of implantable contraception for trained clinicians with Nexplanon. Education / Certificates: Licensed Advanced Pra

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Contract

Depends on Experience

Regulatory & Clinical Affairs Manager

Princeton, New Jersey

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9d ago

Role: Regulatory & Clinical Affairs Manager Locations : Princeton, NJ (Onsite) (Full Time /Permanent) Note* FULLTIME Role and This role is on-site at Princeton, NJ The Role The Regulatory & Clinical Affairs Manager will play a key role in supporting the Company s regulatory and clinical initiatives across product development, regulatory submissions, and hospital collaborations. This position is intended for a motivated professional seeking to grow into increasing levels of responsibility withi

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Full-time

$160,000 - $170,000

CSV Consultant

Hybrid in Raritan, New Jersey

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19d ago

We are seeking an experienced CSV Consultant with expertise in Computer System Validation (CSV), SAP ERP, and Generative AI/Agentic AI in a GxP-regulated environment. The ideal candidate will have strong experience validating enterprise applications while ensuring compliance with FDA and global regulatory standards. Key Responsibilities: Perform Computer System Validation (CSV) activities for SAP ERP, WMS, and enterprise applications.Develop and execute validation documentation, including Valida

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Contract

45 - 50

CMO Digital Liaison & Data Steward

Remote

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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

Principal Maximo Integration Architect / M&A Cutover Lead

Ridgefield, New Jersey

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14d ago

Company Overview: Req ID: 382881 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 Principal Maximo Integration Architect / M&A Cutover Lead to join their team in Ridgefield, New Jersey (US-NJ), United States (US). Job Description: Job Description Principal Maximo Integration Architect / M&A Cutover Lead J

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Contract

Depends on Experience

SAP Security Consultant - Remote

Remote

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4d ago

Title: SAP Security Consultant - Remote Mandatory skills: SAP GRC, AC/PC, SAP BTP Technologies, enterprise-wide system solutions, SAP Security Role Design, user administration, SAP security requirements, SOX, FDA validation, SAP authorization management, SHS compliance requirements, SAP Audit Management, SAP ECC, S/4 HANA, SAP HANA, SAP BI NetWeaver, Fiori, SAP RISE, SAP GTS, SAP NFP, SAP MES, SAP BI systems, supporting tools, Security Weaver, SHARP, SAP role management, SAP Identity Management,

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Contract

52 - 57

SAP QM Consultant (Life Sciences)

Hybrid in Jersey City, New Jersey

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27d ago

Required Skills: 14+ years of SAP QM experience Strong Life Sciences/Pharma/Biotech background SAP S/4HANA experience Expertise in Quality Inspection, Quality Notifications, Batch Management, and QM integration with MM/PP Knowledge of GxP, GMP, and FDA 21 CFR Part 11

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Full-time

Depends on Experience

CSV Lead

Hybrid in Raritan, New Jersey

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Today

Job Title: CSV Lead Location - Raritan, NJ (Hybrid) W2/C2C Mandatory Skills - LIMS Lab Vantage & CSV Job Summary: Experience in the Pharmaceutical, biotechnology with LIMS Labvantage related System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Knowledge of FDA guidances and industry standards (i.e., GAMP) Experience in writing and executing documentation for all as

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Contract, Third Party

55 - 60

Project Manager - Pinnacle 21, GXP | 100% Remote | Contract

Remote

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4d ago

Our direct client a large global R&D driven pharmaceuticals company is seeking to hire a Project Manager for their Pinnacle 21 upgrade project.This is 6 months plus contract. Job Title: Project Manager - Pinnacle 21 upgrade project Duration: 6 months (may extend) Location: 100% Remote (work per eastern time)Pinnacle 21 solution is critical for SQS.For this role client is looking for System upgrade experience as a Project Manager and from IT perspective.The tool provides the quality of submissio

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Contract

Depends on Experience

Process Validation Engineer

Newark, New Jersey

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Today

Job Description: We are seeking an experienced Process Validation Engineer to support new pharmaceutical manufacturing projects within a sterile GMP environment. This role will focus on process validation, technology transfer, and qualification activities for pre-filled syringe (PFS) manufacturing lines. The ideal candidate will have strong experience with aseptic processing, PPQ execution, and cross-functional collaboration to ensure successful project delivery and regulatory compliance. Respon

Full-time

Chemist II - Analytical Chemistry (HPLC, cGMP)

South Plainfield, New Jersey

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Today

Chemist II - FDA cGMP Analytical Lab | 100% Onsite | Growing Pharmaceutical Testing Laboratory This Jobot Job is hosted by: Ron Calhoun Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $70,000 - $80,000 per year A bit about us: Founded over 20 years ago and based in South Plainfield, NJ, we are an FDA-registered, cGMP-compliant analytical testing laboratory specializing in OTC drugs, pharmaceuticals, cosmetics, dietary supplements, and botan

Full-time

USD 70,000.00 - 80,000.00 per year

Clinical Information Specialist

Remote

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Today

Clinical Information Specialist / REMOTE / Contract Role About our Customer & Role: Our DIRECT customer, a global leader in Pharmaceutical industry is seeking an experiencedClinical Information Specialist with at least 5 years of experience, in Womens Health Clinical Practice. The Clinical Liaison acts as a liaison for healthcare providers, supporting the clinical use of implantable contraception for trained clinicians with Nexplanon. Education / Certificates: Licensed Advanced Practice Registe

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Contract

70 - 80

FDA jobs in New Jersey, USA