GxP IT QA Specialist: Regulatory and Validation Expert
Doist
Orion Innovation is a premier, award-winning global firm delivering business transformation and product development rooted in digital strategy, experience design, and engineering. The QA professional will lead GxP IT QA efforts across GPS and R&D regulatory compliance through the software validation lifecycle. Ideal candidates will have GMP/GCP/GLP/GVP knowledge, FDA/EU regulatory familiarity, and hands-on experience with validation deliverables, test scripts, and data integrity challenges. #J-18808-Ljbffr Doist
- Orion Innovation is seeking a seasoned GxP IT Quality Assurance professional in New Jersey to lead QA activities for GPS and R&D computerised systems. The role covers validation lifecycle, regulatory compliance, and cross-functional collaboration with IT validation and...Regulatory
- Rocket Pharma is seeking a motivated Specialist, IT - GxP Technical Support to deliver frontline helpdesk... ...compliant. You will collaborate with QA, CSV, Infrastructure, and vendors to ensure audit readiness and ongoing regulatory compliance, while maintaining excellent...Regulatory
- ...solutions provider in Rahway, New Jersey, seeks an IT Support Specialist to build and support laboratory computing systems in... ...tasks, excellent communication skills, and knowledge of GxP operations according to regulatory standards. Ideal candidates will ensure smooth IT...RegulatoryRemote work
- A leading technology consulting firm is looking for an Experienced Validation Lead to support the end-to-end validation of a Unified Regulatory Platform built on Veeva and AWS cloud technology. The ideal candidate will have over 8 years of experience in Computer System...Regulatory
- ...Organization services. It is one of the market leaders... ...the Quality Assurance Specialist III will ensure systems... ...regard to internal, regulatory, and industry standards... ...reports, method validation reports, research and development... ...personnel in GXP/ISO procedures, practices...RegulatoryFull timeContract workFor subcontractorMonday to Friday
$105k - $110k
Manufacturing IT Systems Specialist: Support both the manufacturing systems and the desktop computing... ...such as GS1. Familiarity with regulatory requirements like DSCSA (Drug Supply... ...and manage digital twins for process validation and continuous improvement. Shopfloor...Regulatory- ...current Good Manufacturing Practices (cGMP) and international regulatory standards for biologics drug substance and drug product manufacture... ...with testing standards, standard operating procedures (SOPs), validation guidelines and regulatory filings Author, compile and maintain...RegulatoryContract workWork at officeFlexible hours
$70k - $75k
...&D, clinical, manufacturing, regulatory, and IP capabilities. We believe... .... The Quality Assurance Specialist is a regular employee in a full... ..., CAPAs, chance controls, validation/qualification, facility preventive... ...: Previous experience for QA I (0 to 2 years or more), QA...RegulatoryFull timeWork at officeLocal areaFlexible hours- ...Strong expertise in Computer System Validation (CSV) processes and methodologies, ensuring compliance with regulatory standards such as FDA 21 CFR Part 11, GxP, and healthcare-specific... ...teams, including quality assurance, IT, and business stakeholders, to ensure...Regulatory
$77.8k - $103.8k
...Control (QC) Engineer – AI-Driven Testing & Validation Position Description CGI is... ...while ensuring compliance with GxP and other regulatory standards. This position can be based... ...Come join our team—one of the largest IT and business consulting services firms...RegulatoryWork at officeLocal area- ...Systems Administrator to join our IT team in Monmouth Junction, NJ.... ..., NuGenesis, OpenLab) in a GxP environment, collaborating... ...analysts, vendors and IT for validation and upgrades. Responsibilities... ...restore and ensuring audits meet regulatory requirements. Hybrid work arrangement...Regulatory
- A leading consulting firm seeks a Director of Compliance & Validation in East Brunswick, NJ. This role involves leading Regulatory Compliance teams and contributing to various client projects within the Life Science sector. Candidates should have over 15 years of relevant...Regulatory
- ...better world.Job Description:Validation Engineer Who You’ll Work... ...work with a team of industry experts to help the world’s leading... ...problems. You will join our Regulatory Compliance Practice and partner... ...seasoned leaders, technical specialists, and subject matter experts...RegulatoryFull timeWork at officeFlexible hours
- ...CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies. * Coordinate with multi-disciplinary validation team and be responsible for the validation... ...which verify if the system is compliant to regulatory and client requirements Reports which summarize...Regulatory
- Amneal is seeking an NOI Investigations Specialist to manage in-depth investigations into quality events that could affect product release and regulatory commitments. You will gather data, perform root-cause analyses, and develop CAPAs to prevent recurrence, communicating...Regulatory
- Director of Compliance & Validation, Life Sciences Location: East Brunswick, New Jersey Who You’ll Work With You will join our East Brunswick... ...in the Life Science market sector in New Jersey. Lead a Regulatory Compliance Validation team for pharmaceutical, biotech and medical...RegulatoryWork at office
$120k - $160k
...Position SummaryThe Manager, IT - GxP Systems & Compliance, is responsible... ...change control coordination, validation support, vendor coordination,... ...integrity, security, and regulatory compliance for GxP systems.... ...in partnership with IT, QA, Validation, Manufacturing, QC...RegulatoryFull timeTemporary workWork at officeLocal areaShift work- ...TPA to join their team. This role involves analyzing LTC insurance policies, facilitating stakeholder communication, and ensuring regulatory compliance. The ideal candidate must possess strong analytical skills, have experience in Agile methodologies, and hold relevant...Regulatory
- ...exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11,... ...Automation, Enterprise IT Applications and Network Infrastructure... ..., migration due diligence, GXP and Non GXP areasProvide guidance and leadership regarding Regulatory Compliance and Quality Management...Regulatory
$96.8k - $137k
...Digital Quality Systems Specialist - Governance, Analytics... ...adhere to rigorous regulatory standards like 21 CFR Part... ...data integrity standards, GxP regulatory requirements... ...continuous access validity and data integrity. Support... ...with Global IT on the integration initiatives...RegulatoryHourly payLocal areaRelocation- ...RSM US LLP is seeking a Temporary AML IT Audit Consultant to support a large global banking client, focusing on AML controls, regulatory remediation, and issue validation. The role requires IT audit experience, control testing, model validation, and strong written...RegulatoryContract workTemporary workRemote workFlexible hours
- ...assurance mindset for computer system validation regulatory expertise to read and interpret global GXP regulations, as well data... ...deliverables, review and approval as a QA Ideal candidate would have prior... ...associated with the GxP IT Quality Assurance (QA) program for...Regulatory
- Rocket Pharma is seeking a detail-oriented Specialist, IT - GxP Technical Support to provide first level helpdesk support for GxP-regulated systems... ...AD in a regulated environment. The role collaborates with QA, CSV, Infrastructure and System Owners to ensure secure,...
- ...Validation Specialist, Computerized SystemsThe Validation Specialist, Computerized... ...validation activities for GxP computerized systems.... ...of validation industry and regulatory requirements.Ability to work... ...audits as a subject matter expert with limited supervision.Interact...RegulatoryWork experience placement
$96.2k - $151.4k
...PADT) External Capabilities, Validation, and Compliance (ECVC) department... ...applicants for a Validation Specialist position available at either... ...quality and external regulatory audits and maintain laboratory... ...and inclusion Experience with IT, computerized systems, software...RegulatoryPermanent employmentFull timeFor contractorsLocal areaFlexible hours- ...healthcare organization is seeking a Senior Patient Safety and GxP Document Oversight Manager in Plainsboro Township, NJ. This role... ..., with strong interpersonal and analytical skills to support regulatory requirements and continuous improvement initiatives in a dynamic...Regulatory
$57.5k - $83.4k
...professionals and functional experts. Each member of our team plays... ...The Quality Assurance Specialist is responsible for ensuring consistent... ...service records, decals, and regulatory compliance.Identify and... .... Travel of up to 75%. Valid Driver's License (required)....RegulatoryFull timeTemporary workPart timeSecond jobWork at officeLocal areaFlexible hours- ...experienced CSV Consultant with expertise in Computer System Validation (CSV), SAP ERP, and Generative AI in a GxP-regulated environment. The ideal candidate will... ...applications while ensuring FDA and global regulatory standards compliance. The role involves developing...RegulatoryRemote jobWork from homeFlexible hours
- ...precious metals transactions while maintaining strong controls, regulatory compliance, and operational efficiency.The Precious Metals... ...monitoring, contractual agreements, and regulatory matters.Delivers expert work in General Commercial with high quality and timeliness,...Regulatory
- ...Management System (QMS) and site compliance programs. You will manage quality processes for deviations, change controls, and cleaning validation, partnering with cross-functional teams to ensure inspection readiness and adherence to cGMP requirements. You will monitor,...
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