21 CFR Part 11 Jobs in Chicago, IL

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SS - Business Quality Assurance role

Apex 2000

•

Remote or Indianapolis, Indiana, USA

Contract, Third Party

Hi Please sendin resume and ph# Business Quality Assurance (BQA) Location = Indianapolis, IN / remote Total Yrs. of Experience - 10-12 YEARS Relevant Yrs. of experience - 7 to 12 years Mandatory skills Strong knowledge in GMP, cGMP, regulatory standards (21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211, ICH Q7) Experience in facing FDA audits associated with pharma manufacturing units Hands-on experience with manufacturing processes, CAPAs, deviations etc. Lead Auditor or any other compliance c
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Posted 60+ days ago | Updated 5 hours ago

Sr Manager, Data Sciences

Thermo Fisher Scientific

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Remote or Chicago, Illinois, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you'll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest inve
Posted 34 days ago | Updated 4 hours ago

Computer Systems Validation Engineer

Corporate Solutions General, Inc.

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Remote or San Francisco, California, USA

Full-time, Part-time, Contract, Third Party

Computer System Validation Engineer (CSV) SFO, CA Onsite Contract Client : Cellares Minimum 10+ Years experience required .5 year in Pharma domain Job Roles and Responsibilities: * Develop, execute, and document test protocols for system qualification, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). * Ensure that software is properly validated and compliant with internal and external standards, such as FDA 21 CFR Part 11, GxP, an
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Posted 3 days ago | Updated 6 hours ago

Computer System Validation Specialist

SGS Consulting

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Remote

Contract

Job Title: Computer System Validation (CSV) Specialist Duration: 08 Months + (Possible Extension) Location: Wilmington, DE 19803 (Remote) Schedule: M-F: 08 AM 05 PM Kindly Do not apply if you are not or Permanent Resident of USA. Qualifications: The official position title is Computer System Validation (CSV) specialist to support the Newark manufacturing facility with validation of new and existing computerized systems.This role will primarily support the Newark manufacturing facility but may r
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Posted 16 days ago

MES Consultant

BOTG LLC

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Remote

Full-time

Location: Remote Job Type: Full-Time / Contract Industry: Life Sciences / Pharmaceuticals / Manufacturing About the Role: We are seeking experienced MES (Manufacturing Execution System) Consultants with strong backgrounds in Electronic Batch Records (EBR) and Master Batch Record (MBR) design, along with hands-on recipe authoring experience. This is a remote position, ideal for professionals with a solid understanding of GMP-regulated environments, especially in pharmaceutical or biotech manufact
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Posted 4 days 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 31 days ago | Updated moments ago

Trackwise Digital Architect

VeridianTech

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Texas, USA

Full-time

Trackwise Digital Architect Remote Requirement Experience with designing and implementing IT systems. Experience with understanding specifications, evaluate current application, gather requirements, and work closely with stakeholders to deliver the right solution Experience working and implementing systems using TrackWise Digital platform. Hands on experience in TrackWise Digital Application setup: Permission Sets, Configuring Platform Custom Settings, Configuring Remote Site Settings, E-s