Fda jobs in reedsville, pa

Reedsville, Pennsylvania

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23d ago

Job Summary: Lead manufacturing quality assessment, remediation, and continuous improvement initiatives for Class II/ medical devices. Evaluate manufacturing processes, process validations, risk management activities, supplier quality systems, and compliance to FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and MDSAP requirements. Drive yield improvement, CAPA effectiveness, quality metrics review, and manufacturing risk reduction programs across regulated manufacturing environments. Key Resp

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Third Party, Contract

55 - 60

Quality engineer / Lead/ Manager - Medical Devices Manufacturing Experience

Reedsville, Pennsylvania

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22d ago

Role: Quality engineer / Lead/ Manager Medical Devices Manufacturing Experience Positions: 5 Openings Location: Reedsville, PA (Day 1 Onsite) Job Summary: Lead manufacturing quality assessment, remediation, and continuous improvement initiatives for Class II/ medical devices. Evaluate manufacturing processes, process validations, risk management activities, supplier quality systems, and compliance to FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and MDSAP requirements. Drive yield

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Contract, Third Party

Depends on Experience

GRC Analyst

Remote

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3d ago

This is a 3 Month Contract to Hire Opportunity. This position is 100% Remote. This is an outstanding opportunity for a Sr. GRC Analyst to participate in large global GRC initiatives that literally save lives. We are a leading global biotech company committed to improving human health through scientific innovation. With a 50+ year legacy of excellence, our publicly traded organization employs over 7,000 global team members, holds 750+ product patents, and generates $6.6 billion in revenue with $1

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Contract

$60 - $70

Regulatory Affairs Specialist Small Molecule

Remote

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Yesterday

Job Title: Clinical Regulatory Affairs Specialist Small Molecule Location: Remote We are seeking a Clinical Regulatory Affairs Specialist with 9+ years of experience supporting small molecule clinical development programs.Key Requirements:Strong experience in Clinical Regulatory AffairsHands-on experience with Veeva Vault TMF or similar.Experience with IND, CTA, and NDA submissionsKnowledge of ICH-Google Cloud Platform, FDA, EMA, and global regulatory requirementsExperience supporting clinical

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Contract, Third Party

Depends on Experience

Bioinformatics Product Owner

Remote

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23d ago

Hello, We are seeking an experienced Product Owner to drive the development of a cutting-edge test designed to identify clinically actionable mutations in patients with solid tumors. This role is crucial in ensuring seamless coordination across software development, bioinformatics, clinical genomics, and regulatory teams to deliver high-quality, compliant, and innovative software solutions for precision oncology. Pay rate : $42 on W2 OR $48 on C2C Location : Remote Key Responsibilities: Define a

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Contract

40 - 45

Pharmacovigilance (PV) Specialist / Drug Safety Case Processing Specialist/Clinical Trial Consultant

Remote

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8d ago

Job Description: Responsible for processing and quality checking (QC) of clinical trial and post-marketing Individual Case Safety Reports (ICSRs). Key responsibilities include case intake, triage, data entry, MedDRA coding, narrative writing, follow-up queries, case reconciliation, and ensuring timely regulatory reporting in compliance with global pharmacovigilance regulations. Required Skills: Bachelors degree in Science or a healthcare-related field. 4+ years of experience in Pharmacovigilance

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Contract

Director - Food & Agri. Business Transformation

Remote

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16d ago

Director - Food & Agri. Business Transformation Mode - Remote (MST) Job Type: Full Time Experience Requirement: 15-20 years: Recent experience must be with a leading consulting firm serving the Food & Agribusiness sector. Preferred employers: Big 4 Consulting or equivalent.Across the overall career span, candidate must possess ~5 years of Industry domain experience in Food & Agribusiness. The ideal candidate should have deep, demonstrable expertise across one or more Food & Agri sub-sectors Ag

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Full-time

Depends on Experience

Trade Compliance Analyst

Remote or New York, New York

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Today

Title: - Trade Compliance Analyst Location: New York, NY, 10001 Duration: 12 months (possible for extensions) Fully Remote Position Job Description: Trade Compliance Analyst Position Summary: The Trade Compliance Analyst is responsible for supporting U.S. import compliance activities and ensuring adherence to U.S. Customs regulations and Partner Government Agency (PGA) requirements. This role partners with customs brokers, government agencies, logistics providers, and internal stakeholders to

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Contract, Third Party

$Market

Project Manager - Life Sciences - Remote

Remote

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30+d ago

Project Manager Life SciencesJob SummaryWe are seeking an experienced Project Manager with strong Life Sciences/Pharmaceutical industry experience to lead and deliver complex projects across business, technology, clinical, regulatory, manufacturing, or operational environments. The ideal candidate will have strong project leadership, stakeholder management, risk management, and cross-functional collaboration skills. Key ResponsibilitiesLead projects from initiation through planning, execution,

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Contract

Depends on Experience

Oracle EBS/ ERP Federal Financials Functional Consultant

Remote

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Yesterday

Position: Sr Oracle EBS/ ERP Federal Financials Functional Consultant Location: Remote for DMV Location only Duration: Longterm VISA: No Constraints Rate: $ Open on W2/C2C No of Positions: Client: SAS Global Services LLC / FDA We work with ( H1b transfers and any EAD) Mandatory Skills: Must have 10+ years of Oracle ERP experience and strong hands on with R12Should be eligible to get public trust clearance and must have worked in the US for the last 5 years.Experience with PRISM, IPP, Travel int

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Contract, Third Party

Depends on Experience

Computer Vision Engineer

Remote

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Yesterday

Role: Computer Vision EngineerLocation: Remote with travel required 50%Duration: 6months with possible extensionRole OverviewWe are seeking a Computer Vision Engineer to own the development and integration of real-time automated visual inspection systems for our pharmaceutical packaging lines. In this role, you will design and deploy edge-based vision models that interface with high-speed cameras and IoT hardware to detect packaging defects, verify serialization, and ensure 100% quality complian

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Contract

Depends on Experience

Sr CAPA Engineer

Remote or Waltham, Massachusetts

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Today

PURPOSE AND SCOPE: Lead the harmonization and standardization of the product transfer process including execution and oversight of the product transfer process for assigned regional/global area. PRINCIPAL DUTIES AND RESPONSIBILITIES: Develop, implement, and maintain Global Product Transfer processes for design and manufacturing product transfer.Ensure product quality is achieved at the receiving manufacturing site level during product transfer projectsPartner with CE vertical quality, R&D team

Full-time

PLM Windchill Solution Architect/ SME

Remote

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Yesterday

Role : PLM Windchill Solution Architect/ SME Location : Remote Type : Contract Required Skills & Experience Windchill Expertise 12+ years of hands-on experience with PTC Windchill. Expertise across: Windchill PDMLink ProjectLink MPMLink PartsLink Change Management Document Management Configuration Management Strong knowledge of Windchill versions 12.x/13.x and roadmap toward Windchill 2027. Experience with Windchill upgrades, migrations, and modernization programs. Technical Skills

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Contract, Third Party

Depends on Experience

PLM Windchill Solution Architect/ SME

Remote

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Today

Position SummaryWe are seeking a highly experienced Windchill PLM Subject Matter Expert to assess the current PTC Windchill environment and develop a strategic upgrade roadmap for Windchill 2027. The ideal candidate will have strong technical and functional expertise in Windchill, PLM transformation, system upgrades, data migration, and integrations within regulated industries, preferably Medical Devices. Key ResponsibilitiesAssess the existing Windchill environment, including configurations, cu

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Third Party, Contract

Depends on Experience

PLM Windchill Solution Architect

Remote

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Today

We are seeking a highly experienced Windchill PLM Subject Matter Expert (SME) to lead the assessment and strategic planning for a future upgrade to PTC Windchill 2027. The ideal candidate will possess deep technical expertise in Windchill, strong business process knowledge, and a proven track record of PLM transformation programs within Life Sciences, Healthcare, or Medical Device organizations. The consultant will evaluate the current Windchill implementation landscape, review customizations an

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Full-time

Depends on Experience

Windchill Solution Architect

Remote

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Yesterday

Job Description: Summary Seeking an experienced Windchill PLM SME to assess the current PTC Windchill landscape and define the upgrade strategy and roadmap for Windchill 2027. Preference for candidates with a strong Medical Devices background; Life Sciences and Healthcare experience will also be considered. Responsibilities Assess existing Windchill configuration, customizations, workflows, data models, infrastructure, and integrations.Evaluate Windchill 2027 readiness, upgrade risks, technical

Contract

$100 - $130

Product Stewardship Engineer-Remote

Remote or Plymouth, Minnesota

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Today

Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Diresh Krishnan at email address can be reached on # . We have Contract role Product Stewardship Engineer-Remote for client at Plymouth, MN. Please let me know if you or any of your friends would be interested in this position. Position Details: Product Stewardship Engineer-Remote- Plymouth, MN Location : Plymouth, MN 55442 (Open to 100% remote candidates, though local candidates willing to work h

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Contract

Depends on Experience

Director of AI Engineering

Remote or Pasadena, California

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Today

Director/Sr Director, AI Engineering (Remote, Full-Time) Join Vita Global Sciences, an innovative leader at the intersection of AI technology and life sciences, driving next-generation clinical data solutions. This is a fully remote, full-time opportunity to own the end-to-end AI/ML engineering strategy, leading advanced biometrics and clinical automation platforms with a global impact. Are you passionate about building scalable, production-level AI platforms in the life sciences space? Vita G

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Full-time

Senior Manager IT Manufacturing Applications

Remote or San Diego, California

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Today

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insig

Full-time

USD 141,800.00 - 236,400.00 per year

Data Engineering Manager

Remote or New York, New York

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Today

About Imagen Imagen Technologies is building the AI-enabled teleradiology practice of the future. We operate the first vertically integrated medical practice and AI development platform focused on reducing diagnostic error and giving radiologists superpowers through industry-leading AI solutions developed in-house. With over $200 million in funding from investors such as Google Ventures and some of the largest clinical networks in the country, we are rapidly expanding this platform across the U

Full-time

USD 200,000.00 - 250,000.00 per year

Fda jobs in Reedsville, PA 17084, USA