fda Jobs in rockville, md

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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 5 hours ago

Regulatory affairs - CMC Manager

Sureminds Solutions

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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 4 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 11 days ago | Updated moments ago

Bioinformatics Engineer (Hybrid)

Quest Diagnostics Inc.

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Remote or Baltimore, Maryland, USA

Full-time

Overview About Haystack Oncology Haystack Oncology, now part of Quest Diagnostics, is a next-generation liquid biopsy company focused on advancing tumor-informed minimal residual disease (MRD) testing. Our proprietary technology enables highly sensitive and specific detection of circulating tumor DNA (ctDNA), improving patient outcomes through earlier detection of residual disease. As we continue to expand our assay portfolio and bring cutting-edge diagnostics to the public, we are seeking a
Posted 50 days ago | Updated 2 hours ago

Computer System Validation Specialist

SGS Consulting

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Remote

Contract

Job Title: Computer System Validation (CSV) Specialist Duration: 08 Months + (Possible Extension) Location: Wilmington, DE 19803 (Remote) Schedule: M-F: 08 AM 05 PM Kindly Do not apply if you are not or Permanent Resident of USA. Qualifications: The official position title is Computer System Validation (CSV) specialist to support the Newark manufacturing facility with validation of new and existing computerized systems.This role will primarily support the Newark manufacturing facility but may r
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Posted 12 days ago

Clinical Research Associate (CRA)

Zachary Piper Solutions, LLC

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Remote

Full-time

Piper Companies is seeking a Clinical Research Associate (CRA) with experience in Oncology clinical trials to join a reputable clinical research organization. This is a full-time/permanent opportunity. Some travel is required (regionally, about 8-10 days out of the month). Candidates must be located in CST or PST in one of the following states: WY, CO, KS, WI, IN, OH, MN, MO, IL, MI, KY, AR, CA, OR, WA, NV, UT, AZ. Responsibilities of the Senior Clinical Research Associate (CRA): Perform site s
Posted 2 days ago | Updated moments ago

UX Writer

Beacon Systems, Inc

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Remote

Contract, Third Party

About Beacon Systems, Inc Beacon Systems, Inc, delivers Program Management, Science, Engineering, and Technology Solutions to Federal, Commercial, State, and Local Agencies. We are a subsidiary of Radiant Digital Solutions. Our Technology support to many DoD Agencies, NASA, Voice of America, FDA, and State Agencies such as State of FL, RI, MS, ND, VA, and WV extends our delivery of solutions worldwide. Position Title: Hybrid UX Designer / UX Writer Duration: Long Term Location: Remote- Orlando,
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Posted 4 days ago

MES Consultant

BOTG LLC

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Remote

Full-time

Location: Remote Job Type: Full-Time / Contract Industry: Life Sciences / Pharmaceuticals / Manufacturing About the Role: We are seeking experienced MES (Manufacturing Execution System) Consultants with strong backgrounds in Electronic Batch Records (EBR) and Master Batch Record (MBR) design, along with hands-on recipe authoring experience. This is a remote position, ideal for professionals with a solid understanding of GMP-regulated environments, especially in pharmaceutical or biotech manufact
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Posted 10 hours ago

Sr. R&D Engineer

Medtronic

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Remote or Irvine, California, USA

Full-time

We anticipate the application window for this opening will close on - 24 Jun 2025 Position Description: Sr. R&D Engineer for Covidien, LP (a Medtronic company) located in Irvine, CA. Multiple positions available. Responsible for providing R&D and quality engineering support to ensure the successful development of Medtronic Neurovascular devices, design transfers, scale-up and ongoing operational support; work with Design and Quality control of Class II and Class medical devices (bare-metal or
Posted 12 days ago | Updated 2 hours ago

Clinical Research Associate

Zachary Piper Solutions, LLC

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Remote

Full-time

Piper Companies is seeking a Clinical Research Associate (CRA) with experience in Oncology clinical trials to join a reputable clinical research organization. This is a full-time/permanent opportunity. Some travel is required (regionally, about 8-10 days out of the month). Candidates must be located in CST or PST in one of the following states: WY, CO, KS, WI, IN, OH, MN, MO, IL, MI, KY, AR, CA, OR, WA, NV, UT, AZ. Responsibilities of the Senior Clinical Research Associate (CRA): Perform site s
Posted 20 days ago | Updated moments ago

Senior UX Designer

Beacon Systems, Inc

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Remote

Contract

Beacon Systems, Inc, delivers Program Management, Science, Engineering, and Technology Solutions to Federal, Commercial State, and Local Agencies. We are a subsidiary of Radiant Digital Solutions. Our Technology support to many DoD Agencies, NASA, Voice of America, FDA, and State Agencies such as State of FL, RI, MS, ND, VA, and WV extends our delivery of solutions worldwide. We are looking for a Senior UX Designer - Remote Request you to make sure your updated Resume highlights all the below-me
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Posted 4 days ago | Updated 3 days ago

Senior UX Designer

Beacon Systems, Inc

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Remote

Contract

About Beacon Systems, Inc Beacon Systems, Inc, delivers Program Management, Science, Engineering, and Technology Solutions to Federal, Commercial, State, and Local Agencies. We are a subsidiary of Radiant Digital Solutions. Our Technology support to many DoD Agencies, NASA, Voice of America, FDA, and State Agencies such as State of FL, RI, MS, ND, VA, and WV extends our delivery of solutions worldwide. Position: Senior UX Designer Location: Remote - Orlando FL Duration: Long Term Summary: We are
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Posted 4 days ago | Updated 4 days ago

Senior Appian Developer

Next Gen Software Solutions LLC

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Remote

Contract

Job Title: Senior Appian Developer Location: Silver Spring, MD (Remote Position) Type: Contract (W2 through Next Gen Software Solutions LLC only No C2C) Duration: 12+ Months (Long-term) Pay Rate: $53 - $58/hour (W2) Note: Candidates must have an FDA Public Trust badge to qualify. Job Description Are you an experienced Appian Developer looking for a long-term opportunity to work on cutting-edge projects in a remote environment? Join Next Gen Software Solutions LLC as a Senior Appian Developer
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Posted 5 days ago | Updated 5 days ago

Systems Support Specialist I

Becton Dickinson & Company

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Remote or Sparks, Maryland, USA

Full-time

Job Description Summary Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find progressive solutions that turn dreams into possibilities. We believe that the human elem
Posted 1 day ago | Updated 2 hours ago

SAP OPAL Label Consultant

Stefanini

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Rome, Lazio, Italy

Contract

Stefanini Group is looking for a SAP OPAL Label Consultant for a globally recognized company! For interested applicants, click the apply button or you may reach out Micah Andres at / for faster processing. Thank you! Job Title: SAP OPal Label Consultant Job Description: We are seeking a skilled SAP OPal (One Platform for All Labels) Label Consultant to join our team. The ideal candidate will be responsible for designing, configuring, and implementing labeling solutions within the SAP environment
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Posted 14 days ago | Updated moments ago

R&D Engineer

Medtronic

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Remote or Fort Worth, Texas, USA

Full-time

We anticipate the application window for this opening will close on - 5 Jun 2025 Position Description: R&D Engineer for Medtronic, Inc located in Fort Worth, TX. Support the Design and development of mechanical and electromechanical devices for Class II and Class medical devices. Perform or develop product verification and validation, test fixtures, test protocols, data acquisition, test methodologies, analyze test data and author test reports in compliance with design control requirements. Cr
Posted 33 days ago | Updated 2 hours ago

AI Engineer

Thermo Fisher Scientific

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Remote or Chicago, Illinois, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join us as an AI Engineer to implement innovative AI and ML methods for our GxP Quality Management System. Key Responsibilities: Build AI Solutions: Develop predictive models, anomaly detection systems, and LLMs to optimize QMS performance.Improve GenAI and LLMs: Apply Generative AI techniques and LLMs to automate and improve tasks like quality events analysis, document reviews, and complaint management.Work wit
Posted 33 days ago | Updated 2 hours ago

Senior Reg Ops Specialist SME

LMI Government Consulting (Logistics Management In

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Remote

Contract

Overview LMI is seeking a Senior Reg Ops Specialist SME to support the Biomedical Advanced Research and Development Authority (BARDA). This position can likely be performed remotely. This position requires the ability to obtain a public trust clearance. The Biomedical Advanced Research and Development Authority (BARDA) was established to support and advance the development of vaccines, therapeutics, diagnostics, and innovative technologies for use during public health emergencies. Candidates w
Posted 55 days ago | Updated 11 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

Sr. Reliability Engineer

Medtronic

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Remote or North Haven, Connecticut, USA

Full-time

We anticipate the application window for this opening will close on - 7 May 2025 Position Description: Sr. Reliability Engineer for Covidien, LP (a Medtronic company) located in North Haven, CT. Responsible for development of reliability testing methodologies for electrical and mechanical components and subsystems, test methods, and validation activities to meet requirements. Interface with cross-functional group members, various suppliers, and test laboratories. Perform data analysis using sta
Posted 60+ days ago | Updated 2 hours ago