QA IT Compliance Manager

4 weeks ago


New York, United States Hays CPA LLC Full time

Responsibilities Responsible for creating standard operation procedures, protocols, and compliance related documents for IT department in accordance with FDA regulatory and compliance requirements. Responsible for the daily operation, troubleshooting, and maintenance of GMP-related information systems to ensure their normal operation and data integrity. Work with user department on daily maintenance and provide support on equipment / instruments and associated system. Participate in the testing, validation, and optimization iterations of computerized systems before they go live. Collaborate with departments such as business and QA in handling quality incidents and providing technical support. Support tasks related to system validation.

Qualifications 8 years of pharmaceutical industry experience, specifically around IT audit, compliance, and IT operations. Be familiar with FDA regulatory requirements on data integrity and data governance on computerized systems. Familiar with FDA regulatory standards, possessing the capability to handle changes, deviations, CAPA (Corrective and Preventive Actions), and similar tasks. Possesses the ability to conduct GMP audits for both internal and external purposes, familiar with related processes and biopharmaceutical regulatory guidelines. Knowledgeable about QMS (Quality Management System), DMS (Document Management System), MES (Manufacturing Execution System), LIMS (Laboratory Information Management System), and WMS (Warehouse Management System) related information systems, with practical experience in implementation, validation, and operational maintenance. Controls experience with systems development life cycle, access management, computer operations, networking, and security Knowledgeable in information security and IT operations (including complex legacy infrastructure/application environments within the manufacturing industry) Skilled in creating documentation, sharing technical information, and training less experienced team members. Ability to work and communicate in a global business environment.



  • New York, New York, United States Michael Page Full time

    About Our Client Our client is foreign investment bank located in New York, NY. They offer a wide range of financial services to both individual and corporate clients, including: Corporate Banking, Retail Banking, International Trade Services, Foreign Exchange Services, and Investment Banking. Job Description The Compliance Monitoring and Testing QA...


  • New York, New York, United States Michael Page Full time

    About Our Client Our client is foreign investment bank located in New York, NY. They offer a wide range of financial services to both individual and corporate clients, including: Corporate Banking, Retail Banking, International Trade Services, Foreign Exchange Services, and Investment Banking. Job Description The Compliance Monitoring and Testing QA...

  • QA Manager

    2 weeks ago


    New York, United States PHARMALOGIC HOLDINGS Full time

    Job DescriptionJob DescriptionPharmaLogic is the fastest-growing SPECT & PET radiopharmaceutical solutions provider and contract development and manufacturing organization (CDMO) with radiopharmacies across North America. We are passionate about expanding the power of radiopharmaceutical technology to provide transformative diagnostic and therapeutic agents...

  • QA Manager

    1 month ago


    New York, United States PHARMALOGIC HOLDINGS Full time

    Job DescriptionJob DescriptionPharmaLogic is the fastest-growing SPECT & PET radiopharmaceutical solutions provider and contract development and manufacturing organization (CDMO) with radiopharmacies across North America. We are passionate about expanding the power of radiopharmaceutical technology to provide transformative diagnostic and therapeutic agents...

  • QA Manager

    21 hours ago


    New York, United States PHARMALOGIC HOLDINGS Full time

    Job DescriptionJob DescriptionPharmaLogic is the fastest-growing SPECT & PET radiopharmaceutical solutions provider and contract development and manufacturing organization (CDMO) with radiopharmacies across North America. We are passionate about expanding the power of radiopharmaceutical technology to provide transformative diagnostic and therapeutic agents...

  • Jr. QA Tester

    2 months ago


    New York, New York, United States IT Excel Full time

    RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON TRAINING IN RESTON VATitle QA Analyst/ Jr. QA Tester/Business Analyst/BA/Jr. Validation EngineerQualificationsBS in Computer Science/ MS Computer Science/ BBA/ MBA/ BS in Biomedical Engineering/ BS in Chemical Engineering/ Engineering degree required from an accredited university or college.Minimum...

  • Jr. QA Tester

    1 day ago


    New York, New York, United States IT Excel Full time

    RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON TRAINING IN RESTON VATitle QA Analyst/ Jr. QA Tester/Business Analyst/BA/Jr. Validation EngineerQualificationsBS in Computer Science/ MS Computer Science/ BBA/ MBA/ BS in Biomedical Engineering/ BS in Chemical Engineering/ Engineering degree required from an accredited university or college.Minimum...

  • QA Manager

    2 weeks ago


    New York, United States Open Systems Technologies Full time

    A financial firm is looking for a QA Manager to join their team in Iselin, NJ.  Compensation: $150-175k Responsibilities: Project Testing  Review requirements, solution, design and other project specific technical documentation Review Test documentation Provide resource and test effort estimation Produce the Project Test Plan Analysing...


  • New York, New York, United States Compliance Recruitment Solutions Full time

    Compliance Consultancy Director - Previous Compliance Funds Experience and 1940 Act/NFA/CFTC Knowledge Required Ref: 4015G3 $200K - $220K + Bonus + Benefits New York City Our Client, a growing and dynamic regulatory consulting firm based in New York and London, are looking to hire an experienced compliance professional to join their New York Regulatory...


  • New York, United States Esprow Full time

    Position SummaryWe are looking for a QA Team Lead (QA Manager) capable to understand the company's products, develop and maintain software test processes and strategies, provide technical leadership, design and develop manual and automated test packs, carry out testing of new and old functionality with exploratory, manual, and automated tests to ensure...


  • New York, United States Esprow Full time

    Position SummaryWe are looking for a QA Team Lead (QA Manager) capable to understand the company's products, develop and maintain software test processes and strategies, provide technical leadership, design and develop manual and automated test packs, carry out testing of new and old functionality with exploratory, manual, and automated tests to ensure...


  • New York, United States Apex IT Full time

    Location: Montgomery MD area Hybrid Note: NO C2C, only W2 opportunity with possibility of transfer Over 10 years in Testing with experience in Data manipulation, Data validation, Data fixes, enhancements, testing, and strong data experience with Automation (Tosca) Strong Team lead exp in onshore-offshore model Well-versed with all stages of Software...


  • New York, United States Esprow Full time

    Position Summary We are looking for a QA Team Lead (QA Manager) capable to understand the company's products, develop and maintain software test processes and strategies, provide technical leadership, design and develop manual and automated test packs, carry out testing of new and old functionality with exploratory, manual, and automated tests to ensure...


  • New York, United States Esprow Full time

    Position Summary We are looking for a QA Team Lead (QA Manager) capable to understand the company's products, develop and maintain software test processes and strategies, provide technical leadership, design and develop manual and automated test packs, carry out testing of new and old functionality with exploratory, manual, and automated tests to ensure...

  • Lab QA Manager

    2 weeks ago


    New York, United States Teledyne Brown Engineering Full time

    Job Summary: Provides support to production areas for quality issues and questions. May participates in external, internal and supplier audits. Maintains documentation on audit findings and is responsible for following up on corrective action plans and areas of nonconformance. At this level, tasks and assignments tend to be general but may involve complex...

  • Sr. Manager of QA

    4 weeks ago


    New York, United States 24 Seven Talent Full time

    Our client in the beverage space is looking to bring a Senior Manager of Quality Assurance to their team on a fulltime basis. The role will sit onsite in Fairfield, CA with some travel involved . The Senior Manager of Quality Assurance will play an integral part in the continued development and improvement of our quality assurance program. This role will...

  • QA Engineer

    3 weeks ago


    New York, United States Austin Fraser Full time

    The QA Engineer is a pivotal role within this organization, serving as the right-hand engineer to the Director of Engineering. This individual will spearhead quality assurance initiatives, collaborating closely with the director on test planning, strategies, and risk mitigation. With expertise in both hardware and software testing, particularly in embedded...

  • QA Tester

    2 weeks ago


    New York, United States Diverse Lynx Full time

    Contract Only!!! State Client experience must be there as QA/Tester. Role: QA Tester Location: (New York) - Remote Job Description: Hence, the purpose of this solicitation is for a vendor to provide 2 QA testing resource onsite to test the entire application for thorough quality assurance testing including all integration points & interfaces for civil exams...

  • QA Architect apr05

    21 hours ago


    New York, United States V15P1TALON Test Client1 Full time

    QA Architect_apr05 **About Company**: Who We Are At ADP, what we do is about people. Although we have a strong history of providing solutions for human resource challenges, we strive to do more than that. We challenge ourselves to anticipate, think forward and take action in a way that empowers us to shape the changing world of work. For over 70 years,...


  • New York, United States Healthee Full time

    It's 2024, and we believe that health benefits should be as simple as breathing. Welcome to Healthee - your digital compass to navigate the vast world of healthcare benefits. Imagine discovering your coverage, identifying the right provider, understanding your costs, and booking an appointment-all in the time it takes to send a tweet! That's what we do, and...