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 26 days ago

Senior Technical Analyst with Pharma domain only

Byteware Inc.

•

Remote or West Point, Pennsylvania, USA

Contract, Third Party

Sr Technical Analyst with Pharma DomainBranchburg or West Point PA (Hybrid) Pharma Domain is must required in Recent experience. Responsibilities:Data Analysis and Reporting:Collect, analyze, and interpret technical data related to pharmaceutical processes, product development, and clinical trials.Generate detailed reports and visualizations to support decision-making and present findings to stakeholders.System and Software Management:Manage and maintain technical systems and software applicatio
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Posted 4 days ago | Updated 13 hours 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 49 days ago | Updated 1 hour ago

Business Quality Assurance (BQA)

Activesoft, Inc.

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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 15 days ago | Updated 14 hours ago

Senior EM Navigation Engineer

Recruitment.ai

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Denver, Colorado, USA

Full-time, Third Party

We are seeking experienced Senior EM Navigation Engineers to join our team in Colorado. The ideal candidates will have a strong background in electromagnetic (EM) navigation systems and proven experience working within the medical device industry. Key Responsibilities: Design, develop, and optimize EM navigation systems for medical device applicationsCollaborate with cross-functional teams (hardware, software, clinical) to ensure accurate and reliable system performanceContribute to system integ
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Posted 4 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 3 days ago | Updated 3 hours ago

SDET Data Quality Engineer

Judge Group, Inc.

•

Denver, Colorado, USA

Full-time

Location: Denver, CO Salary: $65.00 USD Hourly - $75.00 USD Hourly Description: About the job Join a global medical-device & cell-therapy organization as a Senior SDET / Data-Quality Engineer. You'll automate data-quality pipelines on our Azure/Databricks lakehouse to ensure regulatory-grade, analytics-ready datasets for upcoming post-market analytics releases. Responsibilities Design, develop, and maintain automated data-validation frameworks for batch & streaming pipelines in Databricks.
Posted 18 days ago | Updated 3 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana
Posted 13 days ago | Updated 6 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 26 days ago

Appian Developer - Remote!

General Dynamics

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Remote

Full-time

Type of Requisition: Regular Clearance Level Must Currently Possess: None Clearance Level Must Be Able to Obtain: None Public Trust/Other Required: Other Job Family: Software Engineering Job Qualifications: Skills: Appian (Platform), Appian BPM, Appian Process Automation Certifications: None Experience: 4 + years of related experience ship Required: No Job Description: General Dynamics Information Technology is seeking numerous candidatesto fill multiple-level Appian Developer roles on a
Posted 6 days ago | Updated 6 hours ago

UX Designer / UX Writer

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 UX Designer / UX Writer - Remote- Orlando, FLRequest you to make sure your updated Resume highlight
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Posted 5 days ago | Updated 6 hours ago

Human Factors Lead

Apidel Technologies

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Remote

Contract

Human Factors Lead (Fully remote job) Job Description: Reporting to the Medical affairs (MA), this role defines work roles and oversees human factors, user experience, and preclinical activities for direct reports and extended core-team team members. Ensures MA function has necessary skills and resources to execute on develop projects as part of business goals and associates are compliant in following procedures. The Senior Manager will lead a Human Factor reviews and all related activity inclu
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Posted 6 days ago | Updated 5 days ago

Product Owner

Tandym Tech

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Remote

Contract

A leading organization in Washington, D.C., is looking to hire an experienced Product Owner for a Remote, contract role. As a Product Owner, you'll collaborate across technical and business teams to drive product strategy, streamline backlogs, and deliver top-tier functionality that supports organizational growth and innovation. This is an exciting opportunity for a strategic and innovative thinker who thrives in Agile environments and can transform business goals into actionable roadmaps. Abou
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Posted 10 days ago | Updated 7 hours ago

Netsuite Finance Functional Consultant for Parttime

Nsight

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Remote

Contract

We are seeking an experienced NetSuite Functional Consultant for Phase-II of our Finance Implementation initiative. The focus will be on Inventory, Warehouse Management, and GMP-compliant processes. The ideal candidate will have deep experience in NetSuite ERP implementations in regulated environments (Life Sciences, Pharma, or Biotech) and a strong understanding of GxP requirements. Key Responsibilities:Lead the implementation of NetSuite modules for Inventory, Advanced Warehouse Management (WM
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Posted 6 days ago

Infor M3 Implementation Consultant (EDI, Finance, Warehouse)

InfoObjects Inc

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Remote

Contract

Infor M3 Implementation Consultant Location: Remote (North America-based) with some travel as needed Duration: 6-12 Months Contract Description: The client is for a Infor M3 consultant for support with backlog and stabilization efforts. They re targeting one generalist and one each with specializations in EDI, Finance, and Warehouse. Top Priority: EDI ( Integration with Infor M3) Strong experience in Infor M3Expertise with EDI translatorsCurrent EDI team (2 3 people) is overloaded; need hands-o
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Posted 6 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 22 days ago

Senior ALM Administrator

Kforce Technology Staffing

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Remote or Acton, Massachusetts, USA

Contract

RESPONSIBILITIES: Kforce has a client in Acton, MA that is seeking a Senior ALM Administrator to manage, support, and enhance our R&D Application Lifecycle Management (ALM) tools-Helix and Polarion. The Senior ALM Administrator will play a key role in data migration, configuration, system integration, and user support to ensure efficient, compliant, and high-quality product development. Responsibilities: * Administer and configure ALM systems (Helix, Polarion) * Lead data migration and system i
Posted 4 days ago | Updated 1 hour ago

Senior CQV Engineer

Johnson & Johnson

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Remote or Athens, Georgia, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 15 days ago | Updated 6 hours ago

Sr. Ultrasound Acoustic Engineer

Johnson & Johnson

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Remote or Santa Clara, California, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 15 days ago | Updated 6 hours 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 27 days ago | Updated 27 days ago