fda Jobs in illinois

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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

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

LIMS and QC Applications Consultant

Expedite Technology Solutions

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

Systems Engineer

Mindlance

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

Consultant, XRPD for Solid Oral dosage, GI

Eliassen Group

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

SAP Plant Maintenance Consultant

IT Resonance Inc.

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:-

Regulatory Affairs - Labeling Strategy, Senior Manager (Remote)

Zachary Piper Solutions, LLC

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

LabVantage LIMS Specialist Remote Location

Sierra Business Solution LLC

Remote

Third Party, Contract

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

MES Consultant Remote Location

Sierra Business Solution LLC

Remote

Contract, Third Party

MES Functional Consultant Location: Boston, MA Skill: POMSnet, PAS-X 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. ? Familiarity

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

Solution Architect with Pharma & Regulatory Experience

The Dignify Solutions, LLC

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

Food Technologist

U.S. Tech Solutions Inc.

Chicago, Illinois, USA

Contract

Job Description: *Please note: This is onsite in Chicago, IL 60642 (with 25% local travel within Chicago) This role is a potential temp to hire International Travel: 1 trip to Rotterdam (2 weeks) at the start of the project for training * Employment Type: W-2 Overview: Support a product improvement initiative for company s product. Focus on developing and improving thermal processes to enhance product taste and quality. Key Responsibilities: The role will be the bridge between the pilot plant an

Desktop Support

Javen Technologies, Inc

Cordova, Illinois, USA

Contract

Position: IT Analyst/ Desktop Support Location: 22614 ROUTE 84 N, Cordova, IL 61242 - Onsite Duration: 12+ Months (Possible Extension) Hours: 8am-4:30 pm Export control required Drug screen required The analyst is responsible for the IT infrastructure at the site, and may be involved in workstation support, telecom, VOIP support, printers, server support and/or networking Skills Ability to Configure, Deploy, Install, Migrate, Order, Patch, Replace, Support & Triage Site Infrastructure as follo

FSQA Technician

Buckhead Meat and Seafood

Geneva, Illinois, USA

Full-time

JOB SUMMARY Monitor Food Safety & Quality Assurance (FSQA) support/evaluation programs and inspection/audit procedures to ensure compliance of products and processes to corporate and regulatory requirements at a Sysco Specialty Meat and/or Seafood Company. RESPONSIBILITIES Monitoring of FSQA programs including HACCP Program, sanitation standard operating procedures, pest control, good manufacturing practices, approved supplier program, foreign material control, plant sanitation, chemical contr

FSQA Technician

Buckhead Meat and Seafood

Rockford, Illinois, USA

Full-time

JOB SUMMARY Monitor Food Safety & Quality Assurance (FSQA) support/evaluation programs and inspection/audit procedures to ensure compliance of products and processes to corporate and regulatory requirements at a Sysco Specialty Meat and/or Seafood Company. RESPONSIBILITIES Monitoring of FSQA programs including HACCP Program, sanitation standard operating procedures, pest control, good manufacturing practices, approved supplier program, foreign material control, plant sanitation, chemical contr

FSQA Technician - Hiring Immediately

Buckhead Meat and Seafood

Elgin, Illinois, USA

Full-time

JOB SUMMARY Monitor Food Safety & Quality Assurance (FSQA) support/evaluation programs and inspection/audit procedures to ensure compliance of products and processes to corporate and regulatory requirements at a Sysco Specialty Meat and/or Seafood Company. RESPONSIBILITIES Monitoring of FSQA programs including HACCP Program, sanitation standard operating procedures, pest control, good manufacturing practices, approved supplier program, foreign material control, plant sanitation, chemical contr

FSQA Technician - Career Growth Opportunities

Buckhead Meat and Seafood

Elgin, Illinois, USA

Full-time

JOB SUMMARY Monitor Food Safety & Quality Assurance (FSQA) support/evaluation programs and inspection/audit procedures to ensure compliance of products and processes to corporate and regulatory requirements at a Sysco Specialty Meat and/or Seafood Company. RESPONSIBILITIES Monitoring of FSQA programs including HACCP Program, sanitation standard operating procedures, pest control, good manufacturing practices, approved supplier program, foreign material control, plant sanitation, chemical contr

FSQA Technician - Hiring Immediately

Buckhead Meat and Seafood

Hampshire, Illinois, USA

Full-time

JOB SUMMARY Monitor Food Safety & Quality Assurance (FSQA) support/evaluation programs and inspection/audit procedures to ensure compliance of products and processes to corporate and regulatory requirements at a Sysco Specialty Meat and/or Seafood Company. RESPONSIBILITIES Monitoring of FSQA programs including HACCP Program, sanitation standard operating procedures, pest control, good manufacturing practices, approved supplier program, foreign material control, plant sanitation, chemical contr

FSQA Technician - Career Growth Opportunities

Buckhead Meat and Seafood

Hampshire, Illinois, USA

Full-time

JOB SUMMARY Monitor Food Safety & Quality Assurance (FSQA) support/evaluation programs and inspection/audit procedures to ensure compliance of products and processes to corporate and regulatory requirements at a Sysco Specialty Meat and/or Seafood Company. RESPONSIBILITIES Monitoring of FSQA programs including HACCP Program, sanitation standard operating procedures, pest control, good manufacturing practices, approved supplier program, foreign material control, plant sanitation, chemical contr

FSQA Technician - Hiring Immediately

Buckhead Meat and Seafood

Hoffman Estates, Illinois, USA

Full-time

JOB SUMMARY Monitor Food Safety & Quality Assurance (FSQA) support/evaluation programs and inspection/audit procedures to ensure compliance of products and processes to corporate and regulatory requirements at a Sysco Specialty Meat and/or Seafood Company. RESPONSIBILITIES Monitoring of FSQA programs including HACCP Program, sanitation standard operating procedures, pest control, good manufacturing practices, approved supplier program, foreign material control, plant sanitation, chemical contr