fda Jobs in chicago, il

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Lead IT Validation Consultant

Amaze Systems Inc

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New York, USA

Contract, Third Party

Lead IT Validation Consultant Remote Notes : Prior experience in CROs, clinical research organizations, or pharmaceutical/biotech companies. Knowledge of laboratory processes such as PK, TK, and biomarker studies. Experience with integration of LIMS with other lab or enterprise systems (e.g., CDS, ELN, CTMS).Validation or QA certifications a plus. JD: We are seeking an experienced IT Validation Consultant to lead and support the validation of Laboratory Information Management System (LIMS) used
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Posted 18 hours ago | Updated 11 hours ago

Sr Process Design Engineer/Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast)

Jobot

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US

Full-time

Sr Process Design Engineer / Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast) This Jobot Job is hosted by: Tony Barhoum Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $115,000 - $150,000 per year A bit about us: We are a full-service engineering consulting firm providing services for a broad range of projects and clients within the private and public marketplaces. Our design engineers provide cost-conscious, reliable, HVAC, plumbing
Posted 16 hours ago | Updated 9 hours ago

Sr Process Design Engineer/Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast)

Jobot

•

US

Full-time

Sr Process Design Engineer / Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast) This Jobot Job is hosted by: Tony Barhoum Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $115,000 - $150,000 per year A bit about us: We are a full-service engineering consulting firm providing services for a broad range of projects and clients within the private and public marketplaces. Our design engineers provide cost-conscious, reliable, HVAC, plumbing
Posted 2 days ago | Updated 9 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 60+ days ago | Updated 7 hours ago

Document Management Specialist | Remote | Contract

Walker Healthforce

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Remote

Contract

Document Management Specialist | Remote | Contract Walker Healthforce is seeking a Document Management Specialist with +4 years of experience. This is a contract opportunity. CORE REQUIREMENTS:An A.A. in Business or English (or related) with four (4) years of experience OR Bachelor of Arts degree.Strong writing skills with good grammar.Attention to detail.Able to work on multiple documents in parallel.Able to create simple forms and templates.Must be able to use MS Office tools and interact with
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Posted 1 day ago

Quality Associate

Stefanini

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Deerfield, Illinois, USA

Contract

Stefanini Group is hiring! Stefanini is looking for Quality Associate in Deerfield, IL (Hybrid) on W2 only. For quick Apply, please reach out to Tuhin Podder- call: /email: Work Hours: M-F (40 hours) Work Location: Deerfield, IL (Hybrid) Shift: 1st Shift Responsibilities:Provide post market surveillance support by owning and resolving issues within complaint trending.Define product families and their associated problem codes and components to improve complaint handling and complaint trending.Upd
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Posted 19 days ago | Updated 8 hours ago

Manufacturing Supervisor - 3rd Shift

BAXTER

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Des Plaines, Illinois, USA

Full-time

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform h
Posted 2 days ago | Updated 20 hours ago

Senior Manager, Data Analytics

Quest Diagnostics Inc.

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Remote or Wood Dale, Illinois, USA

Full-time

Overview Reporting to the Director, Program Management QA/RA, the Sr. Manager, Data Analytics - Quality & Regulatory Affairs will lead the development, management, and execution of a best-in-class analytics strategy in support of the QA/RA function. This position is responsible for establishing on-going processes for collecting and transforming data into strategic insights that support risk management, regulatory compliance, operational excellence, and governance reporting. This is a highly vi
Posted 19 days ago | Updated 12 hours ago

Manufacturing Supervisor - 3rd Shift

BAXTER

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Rolling Meadows, Illinois, USA

Full-time

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform h
Posted 2 days ago | Updated 5 hours ago

Engineering Technician

Flextronics

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Buffalo Grove, Illinois, USA

Full-time

Job Posting Start Date 07-09-2025 Job Posting End Date 08-09-2025 Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraord
Posted 3 days ago | Updated moments ago

Manufacturing Supervisor - 3rd Shift

BAXTER

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Lincolnshire, Illinois, USA

Full-time

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform h
Posted 2 days ago | Updated 5 hours ago

Senior Human Factors Engineer

Medline Industries, LP

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Northfield, Illinois, USA

Full-time

Job Summary This position is responsible for leading and conducting Human Factor/Usability activities to ensure medical devices (Class I and Class II) are safe to use in various user environments. This engineer will collaborate with design engineers and divisional teams to improve the product designs (New and existing), specifically the device-user interfaces, including the device, packaging, labeling, and instructions for use while minimizing the potential for misuse and/or use errors. The eng
Posted 29 days ago | Updated 9 hours ago

Director, Radiopharma Technology Strategy and Operations

GE Healthcare

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Arlington Heights, Illinois, USA

Full-time

Job Description Summary The Director, Radiopharma Technical Strategy & Operations will play a pivotal role in providing high-level scientific and technical leadership within the Manufacturing Sciences and Technology (MSAT) team. This position reports directly to the Head of MSAT and is responsible for driving innovation, technical strategy, and process optimization for the radiopharmaceutical manufacturing operations, particularly in the PET radiotracer space. With deep expertise in radiochemist
Posted 7 days ago | Updated moments ago

Engineer II, Systems

ICU Medical, Inc.

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Lake Forest, Illinois, USA

Full-time

Job Description Position Summary The Systems Engineer II will make an immediate impact defining ICU Medical's current and next generation infusion pumps to meet user and stakeholder needs with guidance from more experienced engineers and managers. The successful candidate will have the following traits: Experienced in System Engineering techniques Experienced in the development and maintenance of life supporting medical products Able to work independently with minimal supervision Able to col
Posted 48 days ago | Updated moments ago

Quality Lab Associate II, 2nd Shift

BAXTER

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Elk Grove Village, Illinois, USA

Full-time

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform h
Posted 2 days ago | Updated 5 hours ago

SAP GTS Business Function Implementation Lead (Remote Work)

Source Code Technologies LLC

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Remote

Contract, Third Party

We are seeking an experienced SAP GTS Consultant with expertise in Global Trade Services (GTS), including full lifecycle implementations and hands-on configuration in SAP GTS E4H. The ideal candidate will have deep functional knowledge of compliance management, customs processes (exports/imports), and GTS master data, particularly in trade between the Dominican Republic (DR) and the US.This is a client-facing, lead role requiring strong project leadership, ability to drive results, and hands-on
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Posted 8 days ago

IT Validation Consultant

Unicorn Technologies LLC

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Remote

Contract, Third Party

Title: IT Validation Consultant with experience in Clinical Research Organisation/ Pharmaceutical/Biotech companies Duration: Contract Work Location: Remote Notes: Prior experience in CROs, clinical research organisations, or pharmaceutical/biotech companies. Knowledge of laboratory processes such as PK, TK, and biomarker studies. Experience with integration of LIMS with other lab or enterprise systems (e.g., CDS, ELN, CTMS).Validation or QA certifications a plus. We are seeking an experienced I
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Posted 13 hours ago

SAP project Manager - Supply chain

ARK Infotech Spectrum

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Remote or Plano, Texas, USA

Contract, Third Party

Role: SAP project Manager - Supply chain Location: Remote -End-to-end project execution from initiation to closure across supply chain and digital integration initiatives (5+ years). - Work with functional and technical teams on SAP supply chain modules (MM, WM, SD, PP). Lead requirement analysis, UAT, and cutover planning (4+ years in SAP projects). - Lead data migration and interface projects using ETL tools, middleware, APIs, or EDI systems (3+ years). - Experience in pharmaceutical/life scie
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Posted 15 hours ago

Senior Biostatistician: Pharma experience / Remote

Biogensys

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Remote

Contract

Biogensys is currently hiring Senior Biostatistician with Pharma experience for 6 to 12 months contract on w2. This is a remote position, no corp to corp, or 1099. No sponsorship is available. Senior Biostatistician: Pharma experience / Remote- At least 9-10 years of experienceLead statistical aspects of clinical studies from design to final reportingReview and approve programming deliverables (ADaM datasets, tables, listings, and figures)Proven expertise in SAS and/or R for statistical analysis
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Posted 10 hours ago

Principal Regulatory Consultant Dietary Supplements

Apptad Inc

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New Jersey, USA

Third Party, Contract

Job Description: Job Title: Principal Regulatory Consultant Dietary Supplements (U.S.-Based) Position Type: Contract / Consulting Location: Jersey City, NJ Department: Regulatory Affairs / Corporate Development Position Summary: We are seeking a highly experienced and credentialed Regulatory Consultant to support strategic M&A due diligence initiatives within the dietary supplement industry. This role demands deep understanding of the U.S. regulatory landscape, including DSHEA, FDA cGMPs (21 CFR
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Posted 8 days ago