21 CFR Part 11 Jobs in Denver, CO

1 - 10 of 10 Jobs

SS - Business Quality Assurance roleJob Title - SS - Business Quality Assurance role

Apex 2000Company Name - Apex 2000

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Remote or Indianapolis, Indiana, USA

Third Party, Contract

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

SDET Data Quality EngineerJob Title - SDET Data Quality Engineer

Judge Group, Inc.Company Name - Judge Group, Inc.

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Denver, Colorado, USA

Full-time

Location: Denver, CO Salary: $65.00 USD Hourly - $75.00 USD Hourly Description: About the job Join a global medical-device & cell-therapy organization as a Senior SDET / Data-Quality Engineer. You'll automate data-quality pipelines on our Azure/Databricks lakehouse to ensure regulatory-grade, analytics-ready datasets for upcoming post-market analytics releases. Responsibilities Design, develop, and maintain automated data-validation frameworks for batch & streaming pipelines in Databricks.

NetSuite AnalystJob Title - NetSuite Analyst

Softworld, Inc.Company Name - Softworld, Inc.

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Louisville, Colorado, USA

Contract

Job Title: NetSuite Analyst Job Location: Louisville, Colorado 80020 Onsite Requirements: Biotech / Pharmaceutical / Life Sciences industry experience. NetSuite, Coupa, and Veeva regulatory guidelines such as FDA 21 CFR Part 11 Job Description: POSITION SUMMARY We're looking for an information Technology (IT) analyst to support our Enterprise Systems. This role will report to the Director of IT Enterprise Systems and will provide technical support, maintenance and enhancement of solutions for F

Computer System Validation SpecialistJob Title - Computer System Validation Specialist

SGS ConsultingCompany Name - 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

MES ConsultantJob Title - MES Consultant

BOTG LLCCompany Name - 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

LIMS and QC Applications ConsultantJob Title - LIMS and QC Applications Consultant

Expedite Technology SolutionsCompany Name - 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

Senior CQV EngineerJob Title - Senior CQV Engineer

Johnson & JohnsonCompany Name - Johnson & Johnson

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Remote or Athens, Georgia, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m

Trackwise Digital ArchitectJob Title - Trackwise Digital Architect

VeridianTechCompany Name - 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

Senior Software Quality EngineerJob Title - Senior Software Quality Engineer

Johnson & JohnsonCompany Name - Johnson & Johnson

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Remote or Santa Clara, California, USA

Full-time

Sr Manager, Data SciencesJob Title - Sr Manager, Data Sciences

Thermo Fisher ScientificCompany Name - 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