GXP Jobs

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GxP/SOX Validation Specialist

Advanced Software Talent

•

Newark, California, USA

Full-time

Our direct client is seeking a GxP/SOX validation specialist for the following opening: You will handle, IT GxP Systems will work to maintain a stable GxP systems environment to enhance performance, uptime, and compliance. This person will implement IT GxP policies, procedures, and best practices and serve as the organization s IT GxP Systems. This is an onsite position, with 4 days in the office and 1 day being remote. Responsibilities Build and Own IT GxP Compliance program. Partner with IT
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Posted 7 days ago | Updated 7 days ago

Business Analyst (Immediate Role)

Xoriant Corporation

•

Plainsboro Township, New Jersey, USA

Contract

Title: Business Systems Analyst II - Pharmaceutical Location: Plainsboro, NJ - hybrid role Duration: 6-12 Months Must haves: 1. Accuracy and attention to detail: GxP critical system will be in use which follows a specific process and requires analyst awareness 2. Excellent analytical skills 3. Strong investigative and documentation skills: investigating systems and using clear communications skills to report back on issues 4. Ability to handle multiple systems and related user management tasks
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Posted 7 days ago | Updated 5 days ago

Lab IT Support

RADGOV INC

•

Westborough, Massachusetts, USA

Contract

Onsite Travel to Boston once in a week Description: Lab Systems Administration & ManagementIT Infrastructure supportProcess OptimizationTroubleshooting and Issue ResolutionRegulatory Compliance (FDA, GxP)Risk Assessment and MitigationData Security and PrivacyCross-functional CollaborationTechnical DocumentationTraining and DevelopmentLaboratory Systems: LIMS Lab Vantage, Pathology Imaging (Aperio), GxP Systems, R&D systems, Nexcelom, Eclipse, Spectroflo ,Agilent, Imaging Systems, ThermoFisher, E
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Posted 14 days ago | Updated 1 day ago

Business Systems Analyst

Xoriant Corporation

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Plainsboro Township, New Jersey, USA

Contract

GxP QUALIFICATIONS: A Bachelor's degree in Computer Science, Information Systems, Business Administration or other related field required. Relevant experience may be substituted when appropriate.A minimum of 4 years of relevant experience in Computer Science, IT, programming/systems analysis or other related experience required.Ability to lead a project in the development and implementation of processes and programs.Ability to provide technical solutions to a wide range of somewhat complex probl
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Posted 7 days ago | Updated 1 hour ago

LAB IT Analyst

PDDN Inc

•

Holly Springs, North Carolina, USA

Contract, Third Party

Role: LAB IT Analyst Location: HollySprings, North Carolina Job Type: Contract (C2C/W2) Interview: Phone/Skype Role Description: o Lab analyst for setting up lab instruments and application/software linked to the instruments. Activities performed under this role: o User Administration (User creation, access, check on validity of user accounts ) o Installation (coordination with vendor, interaction with network team, configuration of the instrument with the different applications ) o Pe
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Posted 1 day ago | Updated 1 hour ago

Validation Expert for S4HANA

IDI Consulting

•

Foster City, California, USA

Contract, Third Party

Support of creating and maintaining GxP (GMP, Google Cloud Platform, GLP) quality and compliance environment for SAP S/4 HANA Perform GxP and 21 CFR part 11 assessments and develop validation planDevelop functional risk strategy and perform functional risk assessmentReview user business process documents and user requirements specificationReview functional, technical and configuration design documentsPrepare and/or review Configuration Qualification (CQ), Data Qualification (DQ), Installation Qu
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Posted 12 days ago | Updated 12 days ago

CSV Consultant

Kellton

•

Remote

Contract

Computer Systems Validation Consultant Hazelwood, MO (100% Remote)$54/hr on W212 months with possible extensionW2 Only Job Summary: Interprets and understands relevant GxP regulations and standards and provides coaching/guidance to ensure enforcement and consistent application of GxP requirements Executes, manages and documents the periodic reviews of global GXP IT systems Review and provide coaching/oversight for non-GxP changes (MOCs) Authors and/or reviews GxP technical documents (SOPs, Work
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Posted 2 days ago | Updated 22 hours ago

IT Quality Validation / System Validation / Pharmaceutical (hybrid)

Kellton

•

Nutley, New Jersey, USA

Contract

I am working on this long term contract position for one of my major Pharmaceutical clients . They are looking for string IT Quality validation and Pharmaceutical industry experience. IT Quality Validation Consultant Prepare computer validation documents such as Validation Plans, User Requirements, Configuration Specifications, Test Protocols, and Summary Reports. Prepare Change Control documentation. Execute test scripts. Perform risk assessments. Must be familiar with 21 CFR Part 11. Consult
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Posted 35 days ago | Updated 29 days ago

Senior Director, Medical Safety Science

Milestone Technologies, Inc.

•

San Mateo, California, USA

Contract

Sr Director of Medical Safety (Operations) - NO C2C Location: Foster City, CA.(requires on-site time) MUST BE LOCAL CANDIDATES Contract length:6 months to start - possibility of contract to hire. Compensation: The estimated pay range for this position is USD $120/Hr - USD $135/Hr and is an Exempt role. Exact compensation and offers of employment are dependent on circumstances of each case and will be determined based on job-related knowledge, skills, experience, licenses or certifications, and l
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Posted 30 days ago | Updated 6 days ago

Equipment Validation Engineer

Pyramid Consulting, Inc.

•

Summit, New Jersey, USA

Contract

Immediate need for a talented Equipment Validation Engineer. This is a 06+ Months Contract opportunity with long-term potential and is located in Summit, NJ(Onsite). Please review the job description below and contact me ASAP if you are interested. Job ID:24-21967 Pay Range: $70 - $77/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location). Key Responsibilities: Maintains qualified equi
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Posted 15 days ago

IT PROJECT MANAGER (APPLICATIONS SIDE)

Della Infotech

•

Sunnyvale, California, USA

Contract

IT PROJECT MANAGER (APPLICATIONS SIDE)Location: Sunnyvale, CADuration: 6+ Months contractHYBRID (2 days - Tuesday & Thursday)ONLY LOCAL PROFILES CONSIDERED TOP SKILLS:- Project management (Traditional, Hybrid)- Business applications exp (SAP, salesforce, Integrations)- Medical industry experience- PMP, Agile certifications- Strong Communication- Minimum 10+ years experience (nothing less) Important notes:- Local candidate- Experience on business applications- Strong project management experience
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Posted 14 days ago | Updated 5 days ago

CSV (Pharma) Consultant

Multivision Inc-IL

•

Seattle, Washington, USA

Contract

Job Description and Qualification: 3 to 5+ years of Computer systems validation (CSV) experience in computerized equipment, QC lab and manufacturing systems is requiredAuthor, review and approve GxP computer system lifecycle documentation such as URS, FRS, CS/DS, risk assessments, validation plan, test protocol, summary reports and RTMDevelop and execute test protocols and test scripts (IQ/OQ/PQ) for computerized systemsKnowledge of regulatory requirements and standard best practices, (e.g. GLP/
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Posted 13 days ago

Sharepoint Engineer (Contract to perm)

Tech-Nique Partners

•

Queens, New York, USA

Contract

Contract to Hire / Contract to Perm Must be local to Long Island City and willing to come onsite 2-3 days per week (Tues, Wed, Thur is a flex day) Start Date: ASAP The SharePoint Engineer is responsible for the management, maintenance, and optimization of the company s controlled SharePoint environments within the organization. Installation and Configuration: Creating and configuring SharePoint sites, lists, document libraries, workflows.User Management: Managing user access, permissions, and se
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Posted 9 days ago | Updated 2 days ago

SAP Compliance Lead - King of Prussia, PA (Onsite/Hybrid) - Need Local

ApTask

•

King of Prussia, Pennsylvania, USA

Contract

Only W2-Contract Location: King of Prussia, PA (Onsite/Hybrid) Must have skill(s): CSV, SAP Validation, Product Serialization, DSCSA Job Description: Roles and Responsibilities SAP Compliance Lead 10years Experience in Validating SAP systems in Manufacturing Experienced in CSV activities in Manufacturing related applications like SAP Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with regulatory requirements Working knowledge on end-to-en
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Posted 13 days ago

Senior IT Manager

Hallmark Global Technologies

•

Winston-Salem, North Carolina, USA

Full-time

It's a FTE role based in Winston Salem. Client will pay for relocation. Description: The Senior Manager, GMP Site Systems is responsible for the implementation and support of technology and informatics systems/tools and programs to support the development, implementation, operation, and continuous improvement of GMP Technical Operations including but not limited to manufacturing, quality assurance, quality control, supply chain, patient experience, facilities/engineering, and technical developme
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Posted 5 days ago | Updated moments ago

SAP Regional System Assurance Lead - King of Prussia, PA (Onsite/Hybrid) - Need Local

ApTask

•

King of Prussia, Pennsylvania, USA

Contract

Location: King of Prussia, PA (Onsite/Hybrid) Must have skill(s): CSV, SAP Validation, Product Serialization, DSCSA Job Description: Roles and Responsibilities Regional System Assurance Lead 10 years Experience in Validating SAP/N systems in Manufacturing Experienced in CSV activities in Manufacturing related applications like SAP/Non Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with regulatory requirements Working knowledge on end-to-e
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Posted 13 days ago

Application Security Compliance Manager

Prominds Business Consulting Inc

•

Jersey City, New Jersey, USA

Contract

Application Security Compliance Manager Jersey City, NY( Hybrid 2-3 days onsite) Long term contract Information Security Compliance experienceSox/Audit Experience in Pharmaceutical and Cloud-based software controlsIT Application Security Assessment experienceOT or Make Application Security Assessment experience.Salesforce Apps, using Cloud, AWS connections.Key resumes would be someone who has IT application security experience related to SOX controls. Not Monetary control.SOX there is searching
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Posted 6 days ago | Updated 5 days ago

Senior Manager - R&D Deviation and CAPA Management

ATR International, Inc.

•

Parsippany-Troy Hills, New Jersey, USA

Full-time

Job Description: Primary Responsibilities Lead and facilitate Quality Event Investigations and subsequent CAPA development in accordance with defined timelines and in collaboration with appropriate subject matter experts Build, deploy and reinforce learning tools and materials to support quality event management capability development Oversee the standard and timeliness of deviation and CAPA completion Work with the business process owners to identify issues and improvement requirements and lea
Posted 5 days ago | Updated 1 hour ago

IT Security Compliance Manager

Prominds Business Consulting Inc

•

Remote

Contract

IT Security Compliance Manager Remote Long term contract Information Security Compliance experienceSox/Audit Experience in Pharmaceutical and Cloud-based software controlsIT Application Security Assessment experienceOT or Make Application Security Assessment experience.Salesforce Apps, using Cloud, AWS connections.Key resumes would be someone who has IT application security experience related to SOX controls. NSOX there is searching for SOC 1 or SOC 2 report review.3rd party risk assessment expe
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Posted 6 days ago | Updated 5 days ago

Quality Control Manager

Zachary Piper Solutions, LLC

•

Wayne, Pennsylvania, USA

Full-time

Piper Health and Sciences is currently seeking a Quality Control Manager to support an innovative and reputable Biologics Quality Control Testing company in Wayne, PA. Responsibilities for the Quality Control Manager Serve as lead scientist and SME for new and ongoing NGS assay applications and resources. Oversee a team of scientists and study managers, guiding experimental design and execution. Allocate laboratory personnel for regulated client studies. Ensure adherence to global regulatory gu
Posted 1 day ago | Updated 2 hours ago