FDA Jobs in New York

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Regulatory affairs - CMC Manager

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
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Posted 3 days ago

Data Architect (Medicare & Pharmaceutical Focus)

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
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Posted 20 days ago | Updated 18 hours ago

SAP Plant Maintenance (SAP PM)

IT Resonance Inc.

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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
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Posted 17 days ago

LIMS and QC Applications Consultant

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
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Posted 26 days ago | Updated moments ago

Systems Engineer

Mindlance

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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
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Posted 60+ days ago | Updated 2 days ago

Consultant, XRPD for Solid Oral dosage, GI

Eliassen Group

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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
Posted 51 days ago | Updated 1 hour ago

Need Local | PLM Architect | Edison, NJ(Hybrid)

Envision Technology Solutions

•

New York, New York, USA

Third Party, Contract

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
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Posted 3 days ago | Updated 2 days ago

Industrial Maintenance Technician

fgf brands

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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
Posted 33 days ago | Updated 6 hours ago

Principal Software Quality Engineer (Remote)

Quest Diagnostics Inc.

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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
Posted 60+ days ago | Updated 2 hours ago

Solution Architect with Pharma & Regulatory Experience

The Dignify Solutions, LLC

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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
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Posted 10 days ago | Updated moments ago

Associate Scientist

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
Posted 9 days ago | Updated 10 hours ago

Validation Engineer

Synkriom

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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
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Posted 4 days ago | Updated 2 days ago

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

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
Posted 20 days ago | Updated 2 hours ago

SAP PLM Architect - HYBRID

radient.ai

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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
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Posted 3 days ago

IT Project Manager

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
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Posted 1 day ago | Updated 10 hours ago

Business Systems Analyst

TSR Consulting Services, Inc.

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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
Posted 11 days ago | Updated 10 hours ago

LIMS Bioinformatics Engineer, Associate (Remote)

Quest Diagnostics Inc.

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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
Posted 60+ days ago | Updated 2 hours ago

Compliance Specialist

BCforward

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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
Posted 27 days ago | Updated 2 hours ago

LabVantage LIMS Architect

Macrosoft

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Franklin Township, New Jersey, USA

Third Party, Contract

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
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Posted 60+ days ago | Updated 18 days ago

Director, Engineering

Merck & Company Inc

•

Rahway, New Jersey, USA

Full-time

Job Description We are seeking a strategic and technical leader with expertise in cell culture development & commercialization to lead a team of approximately 10-15 scientists in Rahway NJ, who lead multidisciplinary program teams and execute laboratory activities. The primary objective of the Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department is to provide the technical leadership and laboratory capabilities in support of late-stage pipeline commercialization a
Posted 2 hours ago