fda Jobs in seattle, wa

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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 3 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 50 days ago | Updated 11 hours ago

Clinical Development Scientist - Medical Devices - scientific publications.

APN Software Services, Inc

•

Bothell, Washington, USA

Contract

Please contact Abdul on "" OR email me at "" Notes from the manager: I need a PHD or MD candidate who has a scientist background - This is a requirement. I need someone who has worked in the medical device space who has designed studies for regulatory environments. Reporting protocols experience within this industry also required. US Regulations experience is required and China NPA would be highly desired. I am not looking for a candidate who is a medical writer. Ultrasound, Senior Clinical Dev
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Posted 18 days ago | Updated 2 days ago

Compliance Specialist V (Environmental, Health, and Safety Engineer)

OrangePeople

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Redmond, Washington, USA

Contract

OrangePeople, we're more than a consulting firm-we're a people-first, high-touch organization committed to delivering transformative technology solutions with integrity and passion. Currently, we are seeking an Environmental, Health, and Safety (EHS) Engineer with an emphasis on Laser Safety in Redmond, WA. The EHS Engineer role will primarily support the radiation and laser safety team through area assessments, evaluating equipment purchase requirements, reviewing R&D experiments, and performi
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Posted 60+ days ago | Updated 1 day ago

Benchtop Support Specialist

Sunrise Systems, Inc.

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Bothell, Washington, USA

Contract

Job Title: Benchtop Support Specialist Job ID: 25-07681 Location: Bothell, WA, 98021 Duration: 12 Month's Contract on W2 100% Onsite Scheduled: Flexible to work between 6am and 11pm rotating shifts and on weekends Top Skills:Experience working in a GMP environmentExperience supporting end user Windows environmentCyber Security KnowledgeUnderstanding and experience with Network, databases, servers, and PCsKnowledge of Incident, problem, and asset management3+ years of Experience Planning and lea
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Posted 19 days ago | Updated 6 days ago

Sr Full Stack Engineer

Pinnacle Software Solutions

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Remote

Contract

KFORCE URGENT REQUIREMENT Looking for candidates regarding the following: POSITION Sr Full Stack Engineer LOCATION Remote DURATION 6+ months INTERVIEW TYPE Video VISA RESTRICTIONS None REQUIRED SKILLS 5+ years of experience working in a SaaS-based product development environment or FDA-regulated medical device environmentExperience with programming languages Java, JavaScript, and SQLMust have SaFE Agile framework experienceSpring BootAngular
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Posted 2 days ago | Updated 2 days ago

SAP Plant Maintenance Consultant

IT Resonance Inc.

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Remote

Third Party, Contract

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

Benchtop Support Specialist

BCforward

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Bothell, Washington, USA

Contract

Benchtop Support Specialist BCforward is currently seeking a highly motivated Benchtop Support Specialist for an opportunity in Bothell, WA 98021. Job Title: Benchtop Support Specialist Job Location: 1522 217th Place Southeast - Bothell, WA 98021 Duration: 6+ Months Pay Range: $20-$23/Hr. on W2 Job Description: Our client, a leading pharmaceutical company, is hiring a Benchtop Support Specialist, on a contract basis. Summary: organization working to support, enhance, and maintain compliance
Posted 18 days ago | Updated 3 hours 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 2 days ago | Updated 9 hours ago

Sr. Full Stack Engineer (Remote)

Pinnacle Software Solutions

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Remote

Contract

Position: Sr. Full Stack Engineer Location: Remote Duration: 6+ Months (Contract) Job Overview: We are seeking a Sr. Full Stack Engineer to join our growing team and contribute to the development of cutting-edge SaaS solutions. This is a fully remote role ideal for experienced engineers with a strong background in Java, JavaScript, and SQL, and who are comfortable working in fast-paced, Agile-driven environments. Candidates with experience in FDA-regulated medical device development or SaaS prod
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Posted 2 days ago | Updated 1 day 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 3 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 9 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 1 day ago | Updated 9 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 2 days 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 18 days ago | Updated 9 hours ago