fda Jobs in atlanta, ga

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W2 only Software Quality Assurance Consultant - EST/CST Only - regulatory affairs Medical Devices, software development life cycle risk management and configuration management FDA

APN Software Services, Inc

•

Remote

Contract

Please contact Abdul on "" OR email me at "" Job Responsibilities: Provides guidance and quality oversight of the development, testing strategy, validation, and documentation of biomedical software, ensuring compliance with established procedures and regulatory requirements. 2. Participates as an integral team member in various phases of the Software Development Life Cycle (SDLC), providing timely and meaningful feedback for project documentation including software requirements, design, test pl
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Posted 7 days ago | Updated 2 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 59 days ago | Updated moments ago

Medical Devices Software Program Manager (REMOTE/WEST COAST CANDIDATES)

Amerit Consulting

•

Remote

Contract

Our client, a US Fortune 250 company and a global Medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an Medical Devices Software Program Manager NOTE: THIS IS REMOTE ROLE & ONLY W2 CANDIDATES (NO C2C/1099) Candidate must be authorized to work in USA without requiring sponsorship Position: Medical Devices Software Program Manager(Job Id - # CFNJP00051124) Location: San Diego CA 92130 (Remote) Duration: 6 months + Contract to
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Posted 10 days ago | Updated 1 day ago

Business Quality Assurance (BQA)

Activesoft, Inc.

•

Remote

Contract

Mandatory Skills & Qualifications: Strong knowledge in GMP, cGMP, and regulatory standards:21 CFR Part 1121 CFR Part 21021 CFR Part 211ICH Q7Experience facing FDA audits at pharmaceutical manufacturing sitesHands-on experience with manufacturing processes, CAPAs, deviations, etc.Lead Auditor or any other compliance certifications (preferred)
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Posted 26 days ago | Updated 1 day ago

PTC Arena Consultant

Teknikoz

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Remote

Third Party, Contract

Key Responsibilities:Lead the technical delivery of PLM solutions using PTC Windchill and Arena PLM/QMS. Guide a team of engineers and consultants across India and the USA. Configure, customize, and maintain PLM modules such as BOM, Change Management, Document Control, and Lifecycle Management. Collaborate with business stakeholders to gather requirements and design scalable PLM workflows. Oversee PLM/ERP integrations and ensure data integrity across systems. Provide mentorship, code reviews, an
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Posted 2 days ago | Updated 2 days ago

Regulatory Affairs - Labeling Strategy, Senior Manager

Zachary Piper Solutions, LLC

•

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 is a hybrid position and the ideal candidate will be located in the Atlanta, GA or Raleigh, NC regions. Responsibilities of the Labeling Strategy, Senior Manager: Develop
Posted 7 days ago | Updated 7 hours ago

Controls Engineer Beckhoff TwinCAT & EtherCAT

Intellectt INC

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Johns Creek, Georgia, USA

Contract, Third Party

Job Description: We are seeking an experienced Controls Engineer to join a medically regulated, 24/7 manufacturing facility in Johns Creek, GA. This 8-month engagement focuses on the investigation, enhancement, and validation of Beckhoff TwinCAT PLC systems, including diagnostics, safety integration, and specification monitoring. Key Responsibilities: PLC Program Development: Design, enhance, test, and validate TwinCAT PLC code and EtherCAT networks. Diagnostics & HMI: Improve EtherCAT diagnost
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Posted 10 days ago | Updated 1 day ago

Controls Engineer - Beckhoff TwinCAT PLC

Chabez Tech LLC

•

Johns Creek, Georgia, USA

Contract, Third Party

Position: Controls Engineer Location: Johns Creek, GA Note: Beckhoff TwinCAT PLC experience is mandatory Overview & Objective We are seeking one (1) expert Controls Engineer to support Beckhoff TwinCAT PLC systems in a 24/7 medically regulated (cGMP) environment. This 8-month contract role is focused on: Investigation, development, and testing of PLC programs EtherCAT diagnostics and safety system integration Specification monitoring defeat analysis High-quality documentation in compliance with
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Posted 3 days ago

Controls Engineer--Johns Creek, GA(Day 1 onsite)

Chabez Tech LLC

•

Johns Creek, Georgia, USA

Full-time

Position: Controls EngineerLocation: Johns Creek, GA(Day 1 onsite) Contract Duration: 8 Months Note:Beckhoff TwinCAT PLC experience is mandatoryOverview & ObjectiveWe are seeking one (1)expert Controls Engineerto supportBeckhoff TwinCAT PLC systemsin a24/7 medically regulated (cGMP) environment. This 8-month contract role is focused on:Investigation, development, and testing of PLC programsEtherCAT diagnostics and safety system integrationSpecification monitoring defeat analysisHigh-quality docu
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Posted 15 days ago | Updated 3 days ago

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
Posted 14 days ago | Updated 9 hours ago

Quality Control Chemist I

Sunrise Systems, Inc.

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Johns Creek, Georgia, USA

Contract

Job title: Quality Control Chemist I Job ID: 25-08182 Location: Johns Creek, GA (Onsite) Duration: 24 months Contract on W2 Schedule: Two-week rotating schedule 12-hour shifts. Week 1: Monday, Thursday and Friday. Week 2: Tuesday, Wednesday, Saturday and Sunday. POSITION PURPOSE: Conduct Quality Control testing of materials and production samples as required to support contact lens production, performing assigned tasks according to approved SOP's, methods, and procedures with adherence to cG
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Posted 24 days ago | Updated 1 day ago

Operating Engineer

Cushman & Wakefield

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Peachtree Corners, Georgia, USA

Full-time

Job Title Operating Engineer Job Description Summary Work under general supervision of the Sr. Engineering Manager or Facilities Manager at a GMP regulated facility maintaining FDA quality standards. Job Description Initial three-month training period to gain site familiarity may require work on varied shifts. Ensures optimum and efficient operations of steam plant, chilled water, and other electromechanical systems to achieve various facility operating strategies Perform all work assigned wit
Posted 28 days ago | Updated 9 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 21 days ago | Updated 6 hours ago

Data Architect

HAYS

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Atlanta, Georgia, USA

Contract

Data Architect - CTP - Atlanta, GA - $80.00 -$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 client is seeking a Data Archite
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Posted 52 days ago | Updated 6 hours ago

Senior Manager Regulatory Affairs - Heart Failure (on-site)

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 family, be your true self and live a full life. Yo
Posted 60+ days ago | Updated 11 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 44 days ago | Updated 6 hours ago

Delta V Automation Engineer

Zachary Piper Solutions, LLC

•

Remote

Full-time

Piper Companies is seeking a Delta V Automation Engineer to join a growing leader in the pharmaceutical/biotechnology space for a contract , remote position. The Delta V Automation Engineer will oversee DeltaV DCS automation systems in a cGMP pharmaceutical environment, managing system integration, documentation review, and cross-functional coordination while ensuring compliance with FDA regulations and validation requirements. Responsibilities of the Delta V Automation Engineer include: Acti
Posted 19 hours ago | Updated 7 hours ago

Delta V Automation Engineer

Zachary Piper Solutions, LLC

•

Remote

Full-time

Piper Companies is seeking a Delta V Automation Engineer to join a growing leader in the pharmaceutical/biotechnology space for a contract, remote position. The Delta V Automation Engineer will oversee DeltaV DCS automation systems in a cGMP pharmaceutical environment, managing system integration, documentation review, and cross-functional coordination while ensuring compliance with FDA regulations and validation requirements. Responsibilities of the Delta V Automation Engineer include: Active
Posted 1 day ago | Updated 7 hours ago

Drug Safety Scientist

Sunrise Systems, Inc.

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Remote

Contract

Job Title Drug Safety Scientist Job ID: 25-08470 Location: 100% Remote (Candidates should be in EST only) Duration: 12 months on W2 Contract Summary: Seeking an experienced Drug Safety Scientist with 5+ years in pharmacovigilance to support regulatory safety reporting and risk management. Must hold a Bachelor's/Master s in Pharmacy, Biotechnology, or Chemistry. Key Responsibilities: Author safety reports (DSUR, PBRER, PADER)Support signal detection and safety data evaluationConduct literature
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Posted 4 days ago | Updated 1 day ago

Remote Senior QA Test Manger/QA Leader with Strong Healthcare Domain

Infinite Computer Solutions (ICS)

•

Remote

Full-time

Note : GCEAD, L2EAD, consultant can apply for this position who can work on W2. Job Descriptions : We are looking for an experienced Senior QA Healthcare Manager/QA Leader to lead the quality assurance team in ensuring the reliability, security, and compliance of healthcare applications. The ideal candidate should have a strong background in healthcare software testing, regulatory compliance (HIPAA, CMS, FDA), test automation, and team leadership. Key Responsibilities: Lead and manage the QA t
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Posted 4 days ago