fda Jobs in atlanta, ga

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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 5 days ago

SAP Plant Maintenance (SAP PM)

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
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Posted 19 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 28 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 1 day 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 53 days ago | Updated 5 hours ago

Regulatory Affairs - Labeling Strategy, Senior Manager (Remote)

Zachary Piper Solutions, LLC

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Remote or Atlanta, Georgia, USA

Full-time

Piper Companies is Senior Manager for Regulatory Affairs Labeling Strategy to join the team a global biopharmaceutical company focused in neurology and immunology. In this role, you will lead labeling strategies, ensuring compliance with regulatory requirements while supporting product development and commercialization. This preferred candidate will be located in the Atlanta, GA or Raleigh, NC regions, however candidates outside of these regions will be considered as well. Responsibilities of
Posted 1 day ago | Updated 3 hours ago

Verification & Validation Engineer

Axiom Software Solutions

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Atlanta, Georgia, USA

Contract

As a Verification & Validation Engineer, you will be part of the team working on verification of embedded software and validation of non-product software tools. You will be creating the test protocols, reports and supporting documentation to comply with Client SOPs and applicable regulations. Duties and Responsibilities: Analyze requirements, develop test protocols, document reports to verify & validate product software and custom non-product software applications developed in house.Develop and
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Posted 14 days ago

Senior Cybersecurity Analyst

Codeforce 360

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Atlanta, Georgia, USA

Contract

Career Opportunity: Job Title: Senior Cybersecurity Analyst About CodeForce 360 Making a career choice is amongst the most critical choices one can make, and it's important for the choice to be calculated with factors such as a company's run of success since its inception and more. But, when you come across a company that has reputation proven with nothing but an illustrious run of success since the day it began, you don't need to think of anything else. That's precisely what some of our emp
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Posted 32 days ago | Updated 20 hours ago

Staff Embedded Software Engineer

Abbott Laboratories

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Atlanta, Georgia, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full li
Posted 6 days ago | Updated 4 hours ago

Senior Supplier Quality Engineer

Avanos Medical

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Alpharetta, Georgia, USA

Full-time

Requisition ID: 6479 Job Title: Senior Supplier Quality Engineer Job Country: United States (US) Here at Avanos Medical, we passionately believe in three things: Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do;Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation;Having an impact on the healthcare challenges we all face, and the lives of people and communities
Posted 3 days ago | Updated 3 hours ago

Network Engineer

Resolution Technologies

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Georgia, USA

Full-time

Network Engineer Network Engineer Description The Network Engineer oversees the design, configuration, testing, and delivery of sophisticated network and security solutions in a global IT setting. This position is crucial for key sites in the U.S. and Germany, along with locations throughout EMEA, LATAM, and APAC. The ideal candidate should prioritize critical thinking, take initiative, and adopt a proactive stance. They will engage directly in project execution, blending technical skills with
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Posted 13 days ago | Updated 2 hours ago

Senior Supplier Quality Engineer

Avanos Medical

•

Alpharetta, Georgia, USA

Full-time

Requisition ID: 6479 Job Title: Senior Supplier Quality Engineer Job Country: United States (US) Here at Avanos Medical, we passionately believe in three things: Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do; Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation; Having an impact on the healthcare challenges we all face, and the lives of people and communities a
Posted 11 days ago | Updated 2 hours ago

SAP Plant Maintenance Consultant

IT Resonance Inc.

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Remote

Contract, Third Party

Hi, Here is an Remote Contract Job opportunity for below position. Role: SAP Plant Maintenance (PM) Consultant Location: IL, Remote + (Occasional Travel) Contract Duration: 12+ Months Experience: 10 + Year skills compliance with food industry standards (e.g., FDA, GMP, HACCP) Regards, Nirmal Kumar Phone:- Email:-
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Posted 19 days ago

R&D Senior Engineer I, Continuous Improvement

Avanos Medical

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Alpharetta, Georgia, USA

Full-time

Requisition ID: 6447 Job Title: R&D Senior Engineer I, Continuous Improvement Job Country: United States (US) Here at Avanos Medical, we passionately believe in three things: Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do; Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation; Having an impact on the healthcare challenges we all face, and the lives of people and
Posted 33 days ago | Updated 2 hours ago

R&D Senior Engineer I, Sustaining

Avanos Medical

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Alpharetta, Georgia, USA

Full-time

Requisition ID: 6448 Job Title: R&D Senior Engineer I, Sustaining Job Country: United States (US) Here at Avanos Medical, we passionately believe in three things: Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do; Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation; Having an impact on the healthcare challenges we all face, and the lives of people and communities
Posted 33 days ago | Updated 2 hours ago

Computer Systems Validation Engineer

Corporate Solutions General, Inc.

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Remote or San Francisco, California, USA

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

Computer System Validation Engineer (CSV) SFO, CA Onsite Contract Client : Cellares Minimum 10+ Years experience required .5 year in Pharma domain Job Roles and Responsibilities: * Develop, execute, and document test protocols for system qualification, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). * Ensure that software is properly validated and compliant with internal and external standards, such as FDA 21 CFR Part 11, GxP, an
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Posted 18 hours ago

LabVantage LIMS Specialist Remote Location

Sierra Business Solution LLC

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Remote

Third Party, Contract

LIMS Support Engineer Location: Boston, MA Skill: Labvantage experience is must Role Description: ? 3-5 years of experience providing IT support for LIMS systems in a pharmaceutical, biotech, or laboratory setting. ? Experience with LabVantage LIMS is strongly preferred experience with LabWare LIMS also considered. ? Strong understanding of laboratory processes, sample management, and analytical workflows. ? Experience with LIMS system configuration, master data updates, and user management. ? F
Posted 1 day ago

MES Consultant Remote Location

Sierra Business Solution LLC

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Remote

Contract, Third Party

MES Functional Consultant Location: Boston, MA Skill: POMSnet, PAS-X Role Description: ? 3-5 years of experience providing IT support for LIMS systems in a pharmaceutical, biotech, or laboratory setting. ? Experience with LabVantage LIMS is strongly preferred experience with LabWare LIMS also considered. ? Strong understanding of laboratory processes, sample management, and analytical workflows. ? Experience with LIMS system configuration, master data updates, and user management. ? Familiarity
Posted 1 day ago

Regulatory affairs - CMC Manager

Sureminds Solutions

•

Remote

Contract

Title : Regulatory affairs - CMC Manager Location: Remote This will be 100% remote in the US only 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 su
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Posted 6 days 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 12 days ago | Updated moments ago