fda Jobs in rockville, md

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Remote - Senior Project Manager with FDA and GxP experience - CH

Empower Professionals

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Remote

Third Party, Contract

Role: Senior Project Manager location: Remote Duration: 12+ Month Level Skill Core Concepts Expert Product Lifecycle Management (PLM) Systems Windchill, Teamcenter, Change Management, Product Data Management, Configuration Control Expert Medtech Regulatory Compliance Knowledge FDA 510K, PMA, UDI, CE mark, EU MDR, GxP, FURLS, BUDI Expert Stakeholder Management and Influence Cross-functional influence, Stakeholder mapping, SME engagement, Interpersonal diplomacy Proficient Cross-OUs Regulatory Pro
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Posted 9 days ago | Updated 3 days 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 40 days ago | Updated 31 days ago

Regulatory Project/Program Manager (Product DNA ecosystem)

Tellus Solutions

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Remote

Contract

Job Description:As a key team member, the Sr. Regulatory Project Manager-Product DNA brings a leadership opportunity to make an impact supporting the Healthcare Product DNA Program; a major transformational program that will create a connected thread of non-transactional product data to support the entire product lifecycle. This will specifically drive changes and interfaces within our overall eco-system (PLM, MES and ERP). This program is planned as a multi- year program that will have multiple
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Posted 3 days ago

Regulatory affairs - CMC Manager

Sureminds Solutions

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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 23 days ago

Senior Technical Analyst with Pharma domain only

Byteware Inc.

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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 1 day ago | Updated 1 day 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 6 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 46 days ago | Updated 6 hours 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 12 days ago | Updated 2 days 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 6 hours ago

Sr Validation Engineer

Katalyst Healthcares and Lifesciences

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Columbia, Maryland, USA

Full-time

Responsibilities: Responsible for preparing, executing commissioning and qualification documents for a variety of utilities, facility, and process equipment. Develop and execute a variety of validation and FDA compliance related documents/protocols for pharmaceutical equipment. Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team. Excellent leadership skills include the ability to simultaneously organize, and successfully execute
Posted 10 days ago | Updated 12 hours ago

Product Owner - PO 25-23425

Compu-Vision Consulting, Inc.

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Bethesda, Maryland, USA

Third Party, Contract

Job Title: Product OwnerLocation: Bethesda, MD (Hybrid)Duration: 9 Months (Extension Likely) Overview: A government-focused organization is seeking an experienced Product Owner to help lead key digital transformation initiatives. This role requires an individual with a strategic mindset, strong leadership, and the ability to translate complex business objectives into actionable product plans. The ideal candidate is entrepreneurial, collaborative, and deeply knowledgeable about agile methodologie
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Posted 5 days ago | Updated 3 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 32 days ago | Updated 12 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) 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 the world. The position we are seeking to fill will
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Posted 60+ days ago | Updated moments 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 53 days ago | Updated 8 hours ago

Associate Document Control

Apex Systems

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Manassas, Virginia, USA

Full-time

Job#: 2073162 Job Description: Job Title: Quality System Documentation Specialist Duration: Six Months to Temp to Hire Shift: Monday to Friday, 7:00 AM - 3:30 PM Pay Rate: $32/hr Basic Function: The Quality System Documentation Specialist is responsible for the creation and maintenance of Quality System documentation. This role involves communicating any deviations to management and assisting the Quality Assurance team with special projects as required. The specialist must comply with SQF, F
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Posted 17 days ago | Updated moments ago

LabVantage LIMS Specialist Remote Location

Sierra Business Solution LLC

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Remote

Contract, Third Party

LIMS Support Engineer Location: Boston, MA Skill: Labvantage experience is must 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. ? F
Posted 19 days ago | Updated 1 day 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 10 days ago | Updated 12 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 23 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 3 days ago | Updated 12 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 2 days ago | Updated 1 day ago