FDA jobs in New Jersey

Raritan, New Jersey

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17d ago

Job Summary for CSV Engineer - Industry Experience: 3-7+ years of relevant experience in pharmaceutical, biotechnology, or medical device industries. - System Development Lifecycle: Proficient in Computer System Validation (CSV), especially in FDA and/or globally regulated environments. - Regulatory Standards: Strong understanding of GxP standards, risk-based validation, FDA guidances, and industry standards (e.g., GAMP). - Validation Documentation: Skilled in writing and executing validat

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Third Party, Contract

$50 - $56

GRC Analyst

Remote

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3d ago

This is a 3 Month Contract to Hire Opportunity. This position is 100% Remote. This is an outstanding opportunity for a Sr. GRC Analyst to participate in large global GRC initiatives that literally save lives. We are a leading global biotech company committed to improving human health through scientific innovation. With a 50+ year legacy of excellence, our publicly traded organization employs over 7,000 global team members, holds 750+ product patents, and generates $6.6 billion in revenue with $1

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Contract

$60 - $70

Regulatory Affairs Specialist Small Molecule

Remote

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Yesterday

Job Title: Clinical Regulatory Affairs Specialist Small Molecule Location: Remote We are seeking a Clinical Regulatory Affairs Specialist with 9+ years of experience supporting small molecule clinical development programs.Key Requirements:Strong experience in Clinical Regulatory AffairsHands-on experience with Veeva Vault TMF or similar.Experience with IND, CTA, and NDA submissionsKnowledge of ICH-Google Cloud Platform, FDA, EMA, and global regulatory requirementsExperience supporting clinical

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Contract, Third Party

Depends on Experience

Bioinformatics Product Owner

Remote

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23d ago

Hello, We are seeking an experienced Product Owner to drive the development of a cutting-edge test designed to identify clinically actionable mutations in patients with solid tumors. This role is crucial in ensuring seamless coordination across software development, bioinformatics, clinical genomics, and regulatory teams to deliver high-quality, compliant, and innovative software solutions for precision oncology. Pay rate : $42 on W2 OR $48 on C2C Location : Remote Key Responsibilities: Define a

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Contract

40 - 45

CSV Lead

Raritan, New Jersey

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Yesterday

Job Title- CSV Lead Job Location- Raritan, NJ (onsite) Job Description- Candidates need to have hands-on experience in validating and implementing infrastructure systems associated with Infrastructure related applications. Experience in the Pharmaceutical, biotechnology, or medical device industry 2+ years experience with System Development Lifecyle 3+ years experience in Computer System Validation (Based on the role selected) Experience in FDA and/or Global regulated environm

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Contract, Third Party

Depends on Experience

Pharmacovigilance (PV) Specialist / Drug Safety Case Processing Specialist/Clinical Trial Consultant

Remote

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8d ago

Job Description: Responsible for processing and quality checking (QC) of clinical trial and post-marketing Individual Case Safety Reports (ICSRs). Key responsibilities include case intake, triage, data entry, MedDRA coding, narrative writing, follow-up queries, case reconciliation, and ensuring timely regulatory reporting in compliance with global pharmacovigilance regulations. Required Skills: Bachelors degree in Science or a healthcare-related field. 4+ years of experience in Pharmacovigilance

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Contract

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

Director - Food & Agri. Business Transformation

Remote

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16d ago

Director - Food & Agri. Business Transformation Mode - Remote (MST) Job Type: Full Time Experience Requirement: 15-20 years: Recent experience must be with a leading consulting firm serving the Food & Agribusiness sector. Preferred employers: Big 4 Consulting or equivalent.Across the overall career span, candidate must possess ~5 years of Industry domain experience in Food & Agribusiness. The ideal candidate should have deep, demonstrable expertise across one or more Food & Agri sub-sectors Ag

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Full-time

Depends on Experience

Trade Compliance Analyst

Remote or New York, New York

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Today

Title: - Trade Compliance Analyst Location: New York, NY, 10001 Duration: 12 months (possible for extensions) Fully Remote Position Job Description: Trade Compliance Analyst Position Summary: The Trade Compliance Analyst is responsible for supporting U.S. import compliance activities and ensuring adherence to U.S. Customs regulations and Partner Government Agency (PGA) requirements. This role partners with customs brokers, government agencies, logistics providers, and internal stakeholders to

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Third Party, Contract

$Market

Validation Lead

Hybrid in Raritan, New Jersey

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22d ago

Role - Validation Lead Location - Raritan, NJ(Hybrid) Key Responsibilities Candidates need to have hands-on experience in validating GxP GEN AI based solutions and LSMV Safety and PharmacovigilancesystemAbility to manage multiple dispositions for multiple J&J Managers with limited supervision.Ability to manage end-end from Inventory, assessments, remediations to final dispositions; 7-10 years of relevant experience; has experience of leading/advising Junior and Senior resources. Specifically in

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Contract

Depends on Experience

JD Edwards E1 Developer

Rockaway, New Jersey

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Today

Job Title: JD Edwards E1 Developer Location: Rockaway, NJ Duration: Full-Time (FTE, Direct Hire) Schedule: Hybrid Role Job Description: IMPACT: The JDE E1 Developer will play a key role in enhancing and supporting critical business operations by developing, customizing, and optimizing JD Edwards EnterpriseOne solutions. ROLE: Reporting to the Director - Enterprise Systems, the Developer will improve system functionality, resolve technical issues, ensure quality and reliability, and help deli

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Full-time, Part-time, Contract, Third Party

Veeva QMS Business Analyst

Princeton, New Jersey

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Today

Job Title: Veeva QMS Business Analyst Location:Princeton, New Jersey - Hybrid Job Description: We are seeking an experienced Veeva QMS Business Analyst with strong expertise in business requirements gathering, BRD/FRS documentation, gap analysis, and workflow configuration within regulated Life Sciences environments. The candidate will work closely with business stakeholders, Quality teams, and technical teams to analyze business processes, manage system requirements, and support Veeva Qu

Full-time, Third Party

Depends on Experience

Sr. CSV/CSA/Validation Engineer

Raritan, New Jersey

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14d ago

Roles & Responsibilities: Need someone strong with GXP applications, saas/paas, infrastructure, quality, cloud concepts, cloud applications, etc. In addition to validation and regulation experience, the resource should have the following experience: Must be able to Independently support Business Separation activities for Large global & regional GxP Computerized systems. With minimal supervison. Strong CSV Expertise, especially within Acquisition/Divestiture/Separation. bility to manage end-end f

Full-time

R&D Associate (Science)

Montvale, New Jersey

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Today

Our client, in consumer cleaning goods manufacturing is seeking an R&D Associate (Science)to join their team. The ideal candidate will have chemistry, formulation, and team playing skills which will align successfully in the organization. Job Title: Research & Development Associate (Science) Location: Montvale, NJ (local candidates needed) Contract: 10 Months(extension possible) Pay Range: $38 - $45 hourly What?s the Job? \tDevelop new products and technologies driven by consumer insights to

Full-time

Compensation information provided in the description

Oracle EBS/ ERP Federal Financials Functional Consultant

Remote

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Yesterday

Position: Sr Oracle EBS/ ERP Federal Financials Functional Consultant Location: Remote for DMV Location only Duration: Longterm VISA: No Constraints Rate: $ Open on W2/C2C No of Positions: Client: SAS Global Services LLC / FDA We work with ( H1b transfers and any EAD) Mandatory Skills: Must have 10+ years of Oracle ERP experience and strong hands on with R12Should be eligible to get public trust clearance and must have worked in the US for the last 5 years.Experience with PRISM, IPP, Travel int

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Contract, Third Party

Depends on Experience

Computer Vision Engineer

Remote

•

Yesterday

Role: Computer Vision EngineerLocation: Remote with travel required 50%Duration: 6months with possible extensionRole OverviewWe are seeking a Computer Vision Engineer to own the development and integration of real-time automated visual inspection systems for our pharmaceutical packaging lines. In this role, you will design and deploy edge-based vision models that interface with high-speed cameras and IoT hardware to detect packaging defects, verify serialization, and ensure 100% quality complian

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Contract

Depends on Experience

Sr CAPA Engineer

Remote or Waltham, Massachusetts

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Today

PURPOSE AND SCOPE: Lead the harmonization and standardization of the product transfer process including execution and oversight of the product transfer process for assigned regional/global area. PRINCIPAL DUTIES AND RESPONSIBILITIES: Develop, implement, and maintain Global Product Transfer processes for design and manufacturing product transfer.Ensure product quality is achieved at the receiving manufacturing site level during product transfer projectsPartner with CE vertical quality, R&D team

Full-time

Oracle EnterpriseOne (E1) Developer

Hybrid in Parsippany-Troy Hills, New Jersey

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Today

Amtex SystemsInc is an information technology and talent solutions company offering talent and BI consulting to the companies in US for over 25 years. Our solutions are designed to fill resource gaps, by providing the right candidates who deliver value to the organization. Our propensity to nurture and build strong relationships with our clients helps us better understand their business demands and gives us the ability to provide services that are on time and rise above the rest. Title: Oracle E

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Full-time, Third Party

Depends on Experience

PLM Windchill Solution Architect/ SME

Remote

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Yesterday

Role : PLM Windchill Solution Architect/ SME Location : Remote Type : Contract Required Skills & Experience Windchill Expertise 12+ years of hands-on experience with PTC Windchill. Expertise across: Windchill PDMLink ProjectLink MPMLink PartsLink Change Management Document Management Configuration Management Strong knowledge of Windchill versions 12.x/13.x and roadmap toward Windchill 2027. Experience with Windchill upgrades, migrations, and modernization programs. Technical Skills

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Contract, Third Party

Depends on Experience

PLM Windchill Solution Architect/ SME

Remote

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Today

Position SummaryWe are seeking a highly experienced Windchill PLM Subject Matter Expert to assess the current PTC Windchill environment and develop a strategic upgrade roadmap for Windchill 2027. The ideal candidate will have strong technical and functional expertise in Windchill, PLM transformation, system upgrades, data migration, and integrations within regulated industries, preferably Medical Devices. Key ResponsibilitiesAssess the existing Windchill environment, including configurations, cu

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Third Party, Contract

Depends on Experience

FDA jobs in New Jersey, USA