FDA Jobs in Atlanta, GA

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Sr Process Design Engineer/Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast)

Jobot

US

Full-time

Sr Process Design Engineer / Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast) This Jobot Job is hosted by: Tony Barhoum Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $115,000 - $150,000 per year A bit about us: We are a full-service engineering consulting firm providing services for a broad range of projects and clients within the private and public marketplaces. Our design engineers provide cost-conscious, reliable, HVAC, plumbing

Lead IT Validation Consultant

Amaze Systems Inc

New York, USA

Contract, Third Party

Lead IT Validation Consultant Remote Notes : Prior experience in CROs, clinical research organizations, or pharmaceutical/biotech companies. Knowledge of laboratory processes such as PK, TK, and biomarker studies. Experience with integration of LIMS with other lab or enterprise systems (e.g., CDS, ELN, CTMS).Validation or QA certifications a plus. JD: We are seeking an experienced IT Validation Consultant to lead and support the validation of Laboratory Information Management System (LIMS) used

Business Analyst

NTT DATA Americas, Inc

Remote or Pittsburgh, Pennsylvania, USA

Contract

Company Overview: Req ID: 328701 NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. NTT DATA's Client is currently seeking a Cybersecurity Business Analyst to join their team in Pittsburgh, Pennsylvania (US-PA), United States (US). (REMOTE)Job Description: Experience Level: 7-9 years of relevant experience Role Overview: The Business Analyst (BA) wil

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

Document Management Specialist | Remote | Contract

Walker Healthforce

Remote

Contract

Document Management Specialist | Remote | Contract Walker Healthforce is seeking a Document Management Specialist with +4 years of experience. This is a contract opportunity. CORE REQUIREMENTS:An A.A. in Business or English (or related) with four (4) years of experience OR Bachelor of Arts degree.Strong writing skills with good grammar.Attention to detail.Able to work on multiple documents in parallel.Able to create simple forms and templates.Must be able to use MS Office tools and interact with

Statistical Programmer

Georgia IT

Remote

Contract

Statistical Programmer Remote Duration: 12+ Months Rate: DOE Key responsibilities At least 5 years of experience in ADaM/TLF.Create, validate, and maintain SAS programs for data analysis, reporting, and submission deliverablesDevelop analysis datasets (ADaM) and tables, listings, and figures (TLFs) to support statistical analysis in production side.Collaborate with statisticians and data managers to define dataset specifications and outputsEnsure compliance with internal SOPs, CDISC standards,

LIMS - Laboratory Information Management Systems

Javen Technologies, Inc

Remote

Contract, Third Party

Experience with LIMS (Laboratory Information Management Systems) preferably LabVantage Understanding of clinical, research, or diagnostic lab workflows Knowledge of regulatory requirements (GxP, FDA 21 CFR Part 11) Familiarity with lab instruments, integrations, and data flows Working with ELNs (Electronic Lab Notebooks) and lab automation Basic understanding of data security, validation, and integrity in lab system Skills: Business Analysis Skills: Requirements gathering and documentation Proce

Statistical Programmer & Senior Biostatistician

Interpro Inc.

Remote

Contract

Interpro has been in the IT consulting business since 1993 and our employees work on a range of projects across the country.We have a long-term opportunity as described below: Remote working-EST hours Statistical Programmer Key responsibilities At least 5 years of experience in ADaM/TLF.Create, validate, and maintain SAS programs for data analysis, reporting, and submission deliverablesDevelop analysis datasets (ADaM) and tables, listings, and figures (TLFs) to support statistical analysis in pr

Salesforce Architect

cyberThink, Inc.

Atlanta, Georgia, USA

Contract

Description: Short Description Role Purpose The Sr IT Architect is a seasoned member of a team delivering new technology capabilities to the Company s owners, customers, and partners within the organization. The Sr IT Architect helps set the vision and parameters that Agile delivery teams operate within. In addition, the Sr IT Architect helps develop and support governance processes that ensure that team deliverables meet the Company s standards for performance, availability, quality, security,

Salesforce Architect

TechResource Services

Decatur, Georgia, USA

Contract

Salesforce Architect Atlanta, GA Contract to hire The SalesForce Architect is a seasoned member of a team delivering new technology capabilities to the Company's owners, customers, and partners within the organization. The Sr IT Architect helps set the vision and parameters that Agile delivery teams operate within. In addition, the Sr IT Architect helps develop and support governance processes that ensure that team deliverables meet the Company's standards for performance, availability, quality

Validation Support Engineer

Katalyst Healthcares and Lifesciences

Johns Creek, Georgia, USA

Full-time

Roles & Responsibilities: Validation Planning: Develop/update Master Validation Plans (MVP) and individual Validation Plans (VP) for system changes. Required: Proven expertise in CSV (Computer System Validation) methodologies (e.g., GAMP5), FDA regulations (21 CFR Part 11, 210, 211, 820 as applicable), and validation of automated manufacturing/control systems. Experience validating PLC-based systems (Beckhoff Twin CAT experience is a significant plus). Responsibilities: Perform tasks under S

Senior IT Architect

Aditi Consulting

Atlanta, Georgia, USA

Contract

Payrate: $95.00 - $96.00/hr. Summary: The Sr IT Architect is a seasoned member of a team delivering new technology capabilities to the Company s owners, customers, and partners within the organization. The Sr IT Architect helps set the vision and parameters that Agile delivery teams operate within. In addition, the Sr IT Architect helps develop and support governance processes that ensure that team deliverables meet the Company s standards for performance, availability, quality, security, and ma

Sr. Regulatory affairs Consultant-W2 ONLY

VetForce Solutions

Remote

Contract

Sr. Regulatory affairs Our client is a rapidly expanding biotech company based in China that recently partnered with a major pharmaceutical company for research collaboration efforts, in hopes of discovering and developing novel oral drug candidates across multiple therapeutic indications (oncology, immunology, etc.) Our client is looking to bring on a Senior Regulatory Affairs Consultant (Senior/Director Level), who will provide strategic regulatory guidance as the client navigates the regulato

Sr. Salesforce Architect

HAYS

Atlanta, Georgia, USA

Contract

Sr. Salesforce Architect - Contract or CTP - Atlanta, GA\ Hybrid- $ 90.00 - 110.00/hr. The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position. Applicants must be legally authorized to work in the United States. Sponsorship not available. Our cl

Python Developer - (clinical data)

Radiant System, Inc

Remote

Contract

Seeking a Python Developer with strong experience in clinical data standards (SDTM/CDISC) and a background in the pharmaceutical industry. Role involves developing automation pipelines and AI/ML models to transform clinical trial data into SDTM-compliant datasets. Must-Haves: 8+ years in pharma/clinical domain 3+ years Python development SDTM, CDISC, ADaM, raw datasets Experience with AI/ML (NLP, classification) Tools: Pinnacle 21, Define.xml Nice-to-Have: Metadata-driven automation Knowledge of

IT Network Manager

Resolution Technologies

Kennesaw, Georgia, USA

Full-time

IT Network Manager IT Network Manager Description The Network Manager 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 w

Senior Biostatistician

Georgia IT

Remote

Contract

Senior Biostatistician Remote Duration: 12+ Months Rate: DOE At least 8years of experienceIn Addition to the above Statistical Programming II experienceLead statistical aspects of clinical studies from design to final reportingReview and approve programming deliverables (ADaM datasets, tables, listings, and figures)Proven expertise in SAS and/or R for statistical analysisMentor junior biostatisticians and support team developmentEnsure compliance with industry standards (CDISC, ICH, FDA/EMA gu

Senior Biostatistician

System Edge (USA) L.L.C.

Remote

Contract

Position: Senior Biostatistician Location: Remote/EST time zone Contract- Long termAt least 6-8years of experienceIn Addition to the above Statistical Programming II experienceLead statistical aspects of clinical studies from design to final reportingReview and approve programming deliverables (ADaM datasets, tables, listings, and figures)Proven expertise in SAS and/or R for statistical analysisMentor junior biostatisticians and support team developmentEnsure compliance with industry standards (

SAP GTS Business Function Implementation Lead (Remote Work)

Source Code Technologies LLC

Remote

Contract, Third Party

We are seeking an experienced SAP GTS Consultant with expertise in Global Trade Services (GTS), including full lifecycle implementations and hands-on configuration in SAP GTS E4H. The ideal candidate will have deep functional knowledge of compliance management, customs processes (exports/imports), and GTS master data, particularly in trade between the Dominican Republic (DR) and the US.This is a client-facing, lead role requiring strong project leadership, ability to drive results, and hands-on

Data Science/ML Engineer

People Force Consulting Inc

Remote

Contract

We are seeking a highly skilled Senior Machine Learning Engineer to join the Foundational Data Analytics (FDA) Program, a strategic initiative focused on building a modern, intelligent data ecosystem. This role will lead the design, development, and deployment of machine learning models that support enterprise-wide analytics, predictive insights, and healthcare transformation. FDA Program Objectives: Single Source of Truth (SSOT): Build standardized, high-quality data infrastructure ensuring con