fda Jobs in denver, co

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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 4 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 17 days ago

LIMS and QC Applications Consultant

Expedite Technology Solutions

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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 5 hours ago

Senior Supplier Quality Engineer

Jobot

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Aurora, Colorado, USA

Full-time

Full-Time & Direct Hire Senior Supplier Quality Engineer needed for Global Health-Tech Leader! This Jobot Job is hosted by: James Thai Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $90,000 - $120,000 per year A bit about us: Based in Colorado Springs, CO, we are reimagining healthcare through breakthrough technologies and human-centered design. Our company is a global leader in health innovation, creating smart systems that improve lives
Posted 1 day ago | Updated 2 hours ago

Manufacturing Engineer

3D Systems Corporation

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Littleton, Colorado, USA

Full-time

Description What We Are Looking For We are seeking a dynamic engineering professional with proven success in defining complex test plans, setting technical project criteria, and self-managing timelines and budgets. The Manufacturing Engineer will lead technical development and implementation of manufacturing processes, with a focus on medical, industrial, and aerospace manufacturing development including scalable additive manufacturing capabilities for the 3D Systems team in Littleton, Colorad
Posted 10 days ago | Updated 14 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 17 days 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 3 days ago | Updated 3 hours ago

Principal Software Engineer - Platform

Medtronic

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Remote or Lafayette, Colorado, USA

Full-time

We anticipate the application window for this opening will close on - 7 May 2025 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life This is an opportunity to join a world class team of mechanical, electrical and software engineers within Medtronic's Surgical Operations Unit. This is one
Posted 22 days ago | Updated 5 hours 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 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 10 days ago | Updated moments ago

Sr Appian Developer

Techwizens LLC

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Remote

Contract

Job Description- Lead and mentor development team members on best practices. - Develop applications using Appian and integrate with COTS products. - Implement Appian and web-based applications. - Create design documents, target state diagrams, and instructions. - Build Appian applications and integration components in Java. - Provide technical guidance to mid-level developers as needed. - Participate in meetings for design reviews and troubleshooting. - Collaborate with release manager on deploy
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Posted 5 days 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 11 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 3 hours 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 3 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 1 hour 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 11 days ago | Updated 5 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 19 days ago | Updated 3 hours 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 3 days ago | Updated 2 days ago