Fda jobs in raritan, nj

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

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

Senior Android Developer

Remote

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7d 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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27d 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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Contract

Depends on Experience

Regulatory Specialist

Remote

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3d 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

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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

CSV Consultant

Hybrid in Raritan, New Jersey

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20d 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

Regulatory & Clinical Affairs Manager

Princeton, New Jersey

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10d 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

QA Test Engineer

Remote

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25d 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

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

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

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

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

CSV Lead, Hybrid - 69811

Raritan, New Jersey

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Today

CSV Lead, Hybrid We have an immediate need for an experienced CSV Lead with strong expertise in LIMS LabVantage, Computer System Validation (CSV), GxP standards, and risk-based validation to lead validation activities within a regulated Pharmaceutical or Biotechnology environment. This is a hybrid position based in Raritan, NJ for a candidate with deep experience in LIMS LabVantage, CSV, FDA/GxP regulated environments, GAMP, validation planning, requirements documentation, compliance/validation

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Contract

$50.00 - 55.00

CSV Validation Lead

Hybrid in Raritan, New Jersey

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4d ago

Role CSV Validation Lead Location -Raritan, NJ(Hybrid) Job Details: 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on experience in retro-validation activities and 21 CFR remediation projects with knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness. Experience in the Pharmaceutical, biotechnology, or medical device industry. Experience in FDA and/or Global regulated environment with good understanding of GxP standa

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Contract

Depends on Experience

CSV Validation Lead

Hybrid in Raritan, New Jersey

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4d ago

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Contract

Depends on Experience

Validation Lead

Hybrid in Raritan, New Jersey

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6d ago

Role: Validation Lead Location: Raritan, NJ(Hybrid) Duration: 6+ Months Must Have - Computer System Validation Experience M&A related Data Migration and related infrastructure qualification in data Platform domain Job Description: Must be able to Independently support Business Separation activities for Large global & regional GxP Computerized systems. with minimal supervision.Recent experience with Acquisitions/Separations/Divestiture from J&J a huge plus.Strong CSV Expertise, especially withi

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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

CSV Consultant(Computer System Validation ? GenAI, Agentic , SAP

Raritan, New Jersey

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Today

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Contract

USD45.0/HOURLY - USD52.0/HOURLY

Fda jobs in Raritan, NJ, USA