fda Jobs in jersey city, nj

1 - 20 of 86 Jobs

Regulatory affairs - CMC ManagerJob Title - Regulatory affairs - CMC Manager

Sureminds SolutionsCompany Name - Sureminds Solutions

•

Remote

Full-time

PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience preferred. Responsibilities will include, but are not limited to, the following: 1. Participate in the development of the CMC regulatory strategy for post-approval small molecule product submissions, including global supplements/variations and responses to health authority queries. 2. Prep

Data Architect (Medicare & Pharmaceutical Focus)Job Title - Data Architect (Medicare & Pharmaceutical Focus)

ConglomerateITCompany Name - ConglomerateIT

•

Newark, New Jersey, USA

Contract

Job Title: Data Architect (Medicare & Pharmaceutical Focus) Tax Term: 1099 , W2 Only Location: Onsite (NJ/PA preferred; open to strong remote candidates working US Eastern hours) Employment Type: Contract About us Conglomerate IT is a certified and a pioneer in providing premium end-to-end Global Workforce Solutions and IT Services to diverse clients across various domains. Visit us at Our mission is to establish global cross culture human connections that further the careers of our employee

SAP Plant Maintenance (SAP PM)Job Title - SAP Plant Maintenance (SAP PM)

IT Resonance Inc.Company Name - IT Resonance Inc.

•

Remote

Contract, Third Party

SAP Plant Maintenance (SAP PM) 12 months Remote with travel to onsite (Chicago IL) Must have food & beverage manufacturing or consumer packaged goods industry experience Solid/Strong comm skills compliance with food industry standards (e.g., FDA, GMP, HACCP) Regards Stephen DJA stephen at itresonance dot com

LIMS and QC Applications ConsultantJob Title - LIMS and QC Applications Consultant

Expedite Technology SolutionsCompany Name - Expedite Technology Solutions

•

Remote or Bridgewater, New Jersey, USA

Full-time, Contract

Solution Architecture and Design: Lead the design and development of LabVantage LIMS solutions tailored to business and laboratory needs. Develop system workflows, configurations, and integrations with other enterprise systems (e.g., S4 Hana ERP, MES, ELN, SDMS). Define data models, interface designs, and system configurations. Implementation and Deployment: Oversee installation, configuration, and validation of LabVantage LIMS applications. Develop and execute project plans, ensuring timely an

Systems EngineerJob Title - Systems Engineer

MindlanceCompany Name - Mindlance

•

Remote

Contract

Job Description: Must-Haves: 1. Configuration Management Expertise: Proven understanding and application of configuration management principles and best practices within a complex product development environment. 2. Medical Device Experience: Experience working within the medical device industry or other regulated sectors with knowledge of FDA regulations and ISO standards. 3. Jama Connect Proficiency: Hands-on experience using Jama Connect tool to manage requirements management and traceability

Consultant, XRPD for Solid Oral dosage, GIJob Title - Consultant, XRPD for Solid Oral dosage, GI

Eliassen GroupCompany Name - Eliassen Group

•

Anywhere, US

Contract

Description: *Remote role* Our F500 Pharma Client is seeking a consultant with strong technical XRPD expertise in solid oral dosage tablet for NDA readiness. We can facilitate w2 and corp-to-corp consultants. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance. Rate: $190 - $200 / hr. w2 Experience Requirements: Pharmaceutical Drug Development Experience Solid Oral Dosage Experience Str

Need Local | PLM Architect | Edison, NJ(Hybrid)Job Title - Need Local | PLM Architect | Edison, NJ(Hybrid)

Envision Technology SolutionsCompany Name - Envision Technology Solutions

•

New York, New York, USA

Contract, Third Party

Job Title:- SAP PLM Architect Location:- Edison, NJ (Hybrid) Job Type:- Contract Roles and Responsibilities: As an SAP PLM Architect, key responsibility to be the Customers liaison with the third-Party PLM Vendor for the SAP PLM Recipe development solution being offered. Understand Client R&I (Research & Innovation) Product development business Process and Architect/Validate solution design document. Understanding the Integration Touch points of SAP PLM Recipe Development with other SAP modul

Industrial Maintenance TechnicianJob Title - Industrial Maintenance Technician

fgf brandsCompany Name - fgf brands

•

Brooklyn, New York, USA

Full-time

Job Description: Maintenance Technician "To become the world?s greatest baker, we need the world?s greatest team members!" What FGF Offers: FGF believes in Home Grown Talent, accelerated career growth with leadership training, unleashing your potentialCompetitive Compensation, Health & Welfare Benefits including Vision & Dental and flexible options at competitive premiums401k matching programDiscount program - Restaurants, gyms, shopping, etc.Tuition reimbursement Overview: FGF Brands is growi

Principal Software Quality Engineer (Remote)Job Title - Principal Software Quality Engineer (Remote)

Quest Diagnostics Inc.Company Name - Quest Diagnostics Inc.

•

Remote or Secaucus, New Jersey, USA

Full-time

Overview Software Quality Engineer - Principal thinks "outside the box" in the implementation of the Software Design Control and SDLC (software development lifecycle) programs providing Quality Assurance and Regulatory oversight and ensuring compliance with all applicable regulations and incorporations of software industry best practices. This candidate can work in a 100% remote capacity and must be located in the US. Responsibilities This position is responsible for leading Quality Assurance

Solution Architect with Pharma & Regulatory ExperienceJob Title - Solution Architect with Pharma & Regulatory Experience

The Dignify Solutions, LLCCompany Name - The Dignify Solutions, LLC

•

Remote or Raritan, New Jersey, USA

Contract, Third Party

Architect and design IT solutions tailored to global Regulatory Affairs functions, including submissions, registration tracking, labeling, and IDMP compliance. Develop and guide implementation of GenAI solutions (e.g., document summarization, narrative generation, intelligent labeling) for regulatory use cases. Lead end-to-end architectural governance for regulatory systems, including integrations with RIM, DMS, and Health Authority gateways. Design and optimize Cloud-native data pipelines for r

Associate ScientistJob Title - Associate Scientist

TSR Consulting Services, Inc.Company Name - TSR Consulting Services, Inc.

•

Summit, New Jersey, USA

Contract

Our client, a leading pharmaceutical company, is hiring an Associate Scientist, on a contract basis. Job ID #: 82326 Work Location: Summit, NJ - 100% on site Summary: The Associate scientist role within the Microscopy and Spectroscopy Lab (MSL) team in Manufacturing Sciences and Technology (MS&T) group will be responsible for investigations involving the physical and chemical characterization and identification of materials such as unknown components or foreign matter in manufacturing processes

Validation EngineerJob Title - Validation Engineer

SynkriomCompany Name - Synkriom

•

Summit, New Jersey, USA

Contract

Essential Functions: Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures. Develops protocols, and associated reports while adhering to a change management process. Supports the execution of equipment qualifications and validation protocols Supervises vendors for qualification functions. Supports equipment qualification and systems validation activities. Configures and documents the configuration of computerized systems Develops valid

SAP PLM Architect - HYBRIDJob Title - SAP PLM Architect - HYBRID

radient.aiCompany Name - radient.ai

•

Edison, New Jersey, USA

Contract

Job Description: The Requirement for a seasoned Sr. SAP PLM Solution architect with strong Background in SAP Recipe Development for a food & Retail industry. preferably with Domain knowledge of food Industry s (R&I) Research & Innovation process. The ideal candidate should have over 12 years of SAP PLM Recipe Development implementation experience, specifically in the food industry (preferably dairy products). Candidate should have Architected, Demonstrated and configured the SAP PLM Recipe devel

Associate Software Engineer (SQL/Javascript/Python), Lab Information SystemsJob Title - Associate Software Engineer (SQL/Javascript/Python), Lab Information Systems

Quest Diagnostics Inc.Company Name - Quest Diagnostics Inc.

•

Remote or Secaucus, New Jersey, USA

Full-time

Overview Haystack Oncology at Quest Diagnostics is seeking to grow its laboratory informatics team as we expand our assay portfolio and introduce cutting edge diagnostic technology to the public. As a Bioinformatics Engineer - LIMS, you will be responsible for developing, configuring, maintaining, and optimizing key functionality within our cloud-based enterprise Laboratory Information Management System (LIMS) that manages the generation, analysis, quality control, and interpretation of clinic

IT Project ManagerJob Title - IT Project Manager

Robert HalfCompany Name - Robert Half

•

South Plainfield, New Jersey, USA

Full-time

Description We are looking for a skilled IT Project Manager. In this role, you will be responsible for overseeing critical IT projects related to mergers, acquisitions, and divestitures within the pharmaceutical industry. This position offers an exciting opportunity to lead complex initiatives while collaborating with cross-functional teams and senior stakeholders. Responsibilities: Lead the planning and execution of IT projects associated with mergers, acquisitions, and divestitures. Act as a

Business Systems AnalystJob Title - Business Systems Analyst

TSR Consulting Services, Inc.Company Name - TSR Consulting Services, Inc.

•

Summit, New Jersey, USA

Contract

Our client, a leading pharmaceutical company, is hiring a Business Systems Analyst, on a contract basis. Job ID #: 82011 Work Location: Summit, NJ - 100% Onsite Summary: The SAP S4/Hana Business Delivery Lead Systems Analyst is a service oriented, positive, forward thinking team member, who is responsible for implementing and supporting SAP solutions to meet business-related requirements. The SAP S4/Hana Business Systems Analyst collaborates with the business process teams to understand current

Compliance SpecialistJob Title - Compliance Specialist

BCforwardCompany Name - BCforward

•

Summit, New Jersey, USA

Contract

Compliance Specialist BCforward is currently seeking a highly motivated Compliance Specialist in Summit, NJ Job Title: Compliance Specialist Duration:12 months(possibility of extension for right candidate depending on performance) Work Schedule: Need to be flexible to come onsite min 50% as required by manager Location: Summit, NJ Pay Range: $55- $58/ Hr. on W2 Purpose and Scope of the Position The Compliance Specialist, Equipment Commissioning & Qualification, supports the successful operati

LabVantage LIMS ArchitectJob Title - LabVantage LIMS Architect

MacrosoftCompany Name - Macrosoft

•

Franklin Township, New Jersey, USA

Contract, Third Party

Title: LIMS Architect Location: Somerset, NJ (Onsite) Duration: 12 Months Required Skills: 10+ years of experience managing LABVANTAGE LIMS, QC, or other laboratory-related software systems in the biotech or pharmaceutical industries.Proven experience in designing and deploying enterprise-grade LIMS solutions.Familiarity with laboratory processes in industries such as pharmaceuticals, biotech, food safety, or environmental testing.Strong knowledge of database management systems (e.g., Oracle, SQ

LIMS Bioinformatics Engineer, Associate (Remote)Job Title - LIMS Bioinformatics Engineer, Associate (Remote)

Quest Diagnostics Inc.Company Name - Quest Diagnostics Inc.

•

Remote or Secaucus, New Jersey, USA

Full-time

ConsultantJob Title - Consultant

Robert HalfCompany Name - Robert Half

•

Warren, New Jersey, USA

Contract

Description We are offering a long term contract employment opportunity for a Consultant in the Pharmaceutical industry, based in Warren, New Jersey. This role involves substantial interaction with both small and large molecule clinical and preclinical development projects, with a focus on maintaining scientific quality and adhering to regulatory guidelines. Responsibilities: Execute quantitative analysis of biological samples as part of our development projects Develop, validate, and conduct b