fda Jobs in rockville, md

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Document Control Associate

Aditi Consulting

•

Manassas, Virginia, USA

Contract

Payrate: $30.00 - $32.00/hr. Summary: The creation and maintenance of the Quality System documentation. Communicate any deviations to management. Assist the Quality Assurance team with special projects as required. Comply with SQF, Food Safety Plan (HACCP), Food Quality Plan (FQP) standards. Job Duties: Create, revise, and maintain all documentation related to the Quality System using technical writing best practices, ensuring proper formatting, numbering, and document control. Issue batch recor
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Posted 12 hours ago | Updated 5 hours ago

IT Program Manager

AP Ventures

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Columbia, Maryland, USA

Contract

Title: IT Program Manager - FDA Location: Hybrid in Columbia, MD Company Background A P Ventures, LLC (APV) is an innovative Woman-Owned Small Business (WOSB) providing services to Government customers at the federal and state levels in three key focus areas: High-End IT Consulting, Emerging Technology and Training Solutions, and Human Capital Services. Established in 2007, APV has completed 70+ prime contracts and currently oversees 25+ task orders, consistently achieving high client satisfact
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Posted 16 days ago | Updated 7 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 13 days ago

Regulatory affairs - CMC Manager

American IT Systems

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Remote

Contract

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: 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.Prepare a
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Posted 5 days ago | Updated 2 days ago

Proposal Writer / Proposal Development Specialist

ExpediteInfoTech, Inc.

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Rockville, Maryland, USA

Full-time, Contract

Position Summary : The Proposal Writer / Proposal Development Specialist supports the proposal and business development teams in growth activities. This position involves conducting research, proposal writing and content development. Experience in creating compliant proposal responses to Federal solicitations is required. Candidates should have experience collaborating with various stakeholders to develop win themes and value propositions and providing essential proposal development process su
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Posted 60+ days ago | Updated 5 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 22 days ago | Updated 5 hours 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 14 hours ago

Technical Proposal Solutions Architect

ExpediteInfoTech, Inc.

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Rockville, Maryland, USA

Full-time, Contract

Summary: As the Technical Proposal Solutions Architect for ExpediteInfoTech, Inc. (EIT), you will lead overall technical solutions for RFIs, RFPs, RFXs, SSNs, including for IDIQs, BPAs, GWACs, Task Order contracts and technical marketing material including white papers. Providing technical strategies, solutions, and forward-looking advisory services are just a few of the exciting responsibilities of this position.The successful candidate will possess a broad base of core technical knowledge and
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Posted 60+ days ago | Updated 5 hours 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 47 days ago | Updated 10 hours ago

Medical Writer

Zachary Piper Solutions, LLC

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Bethesda, Maryland, USA

Full-time

Piper Companies is seeking a Clinical Project Manager to join a contract research organization located in Bethesda, MD. Responsibilities of the Medical Writer include: Working with both private and public sectors regarding the submission of various documents (scientific or regulatory) Provide different results in regard to document searches and document summaries Manage meeting filings and other documents associated (meeting reports, proceedings, safety documents, data analysis. Etc.) Provid
Posted 1 day ago | Updated 8 hours ago

Computer System Validation (CSV) Engineer (Onsite)

DP Professionals Inc

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Columbia, Maryland, USA

Contract

DPP is seeking a Computer System Validation (CSV) Engineer for our client in Columbia, Maryland. This is a direct hire opportunity. Work arrangement: Onsite W2 position; full time employee Position description: The Computer System Validation Engineer (CSV Engineer) ensures that all computer systems and software used in manufacturing and laboratory environments comply with regulatory requirements and industry standards. This role involves developing, executing and maintaining validation protocols
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Posted 2 days ago | Updated 5 hours ago

SalesForce Architect (Remote DMV Area)

ICF

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Remote or Reston, Virginia, USA

Full-time

*We are open to supporting 100% remote work anywhere within the US. Preferred candidate will sit in US, working Eastern Standard Time. May be required to attend quarterly meetings in Metro DMV area* ICF's Digital Modernization Division is a rapidly growing, entrepreneurial, technology department, seeking a Salesforce Architect. Our services focus on enabling agency mission and business transformation using industry-leading low-code platforms, mobile applications, robotics process automation and
Posted 8 days ago | Updated 11 hours ago

Mechanical Engineer

Apex Systems

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Sterling, Virginia, USA

Full-time

Job#: 2067560 Job Description: Position Title: Mechanical Engineer Type: Direct Hire/Permanent (not contract) Location: Sterling, VA (100% onsite Monday-Friday, no remote work) For immediate consideration, please email resumes to Position Overview: We are currently seeking a Mechanical Engineer who will be responsible for assisting in the mechanical design and building of medical devices. Our company designs, manufactures and sells robotic systems that are used by patients in hospitals around
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Posted 40 days ago | Updated 11 hours ago

Regulatory Affairs Manager

LMI Government Consulting (Logistics Management In

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Frederick, Maryland, USA

Contract

Overview LMI is seeking an experienced Regulatory Affairs Manager to support the Office of Human and Animal Research Oversight (OHARO), Office of Human Research Oversight (OHRO) at Ft. Detrick in Frederick, MD location. Will serve as lead auditor for quality audits (GMP & GLP) of developing and manufacturing investigational countermeasures for MCS. This position can be performed hybrid/remotely with onsite requirements 1 day per week. This position requires the ability to pass a T1/NACI securit
Posted 29 days ago | Updated 7 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 13 days ago

Senior Full Stack Engineer (Remote)

Pinnacle Software Solutions

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Remote

Contract

Job Title: Senior Full Stack Engineer Location: Fully Remote (U.S. based) Duration: 6+ Months Contract Visa Status: No Sponsorship Provided Interview Rounds: 2 About the RoleArc One Solutions is seeking a highly skilled Senior Full Stack Engineer with experience in SaaS-based product development or FDA-regulated environments. The ideal candidate is a self-starter with strong backend and frontend development experience, preferably in cloud-based (AWS) environments. You'll work remotely as part o
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Posted 16 hours ago | Updated 15 hours ago

Technical Support Specialist

Techim INC

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Remote

Full-time

Benchling application support experience, along with GxP background, CSV experience will be added advantage.Provide first-line application support for Benchling users, resolving technical and functional issues.Troubleshoot errors across Benchling modules including Notebook, Registry, Inventory, and Workflows.Escalate complex issues to engineering or product teams with clear documentation.Support deployments and usage in validated GxP environments .Ensure compliance with 21 CFR Part 11, FDA, and
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Posted 12 hours ago | Updated 12 hours ago

IT Lab Coordinator

Techim INC

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Remote

Full-time

Benchling application support experience, along with GxP background, CSV experience will be added advantage.Provide first-line application support for Benchling users, resolving technical and functional issues.Troubleshoot errors across Benchling modules including Notebook, Registry, Inventory, and Workflows.Escalate complex issues to engineering or product teams with clear documentation.Support deployments and usage in validated GxP environments .Ensure compliance with 21 CFR Part 11, FDA, and
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Posted 12 hours ago | Updated 11 hours 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 45 days ago | Updated 11 hours 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 6 days ago | Updated 5 hours ago