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 16 days ago | Updated 16 days ago

Senior Director, GxP Quality

Amgen Inc

•

California, USA

Full-time

HOW MIGHT YOU DEFY IMAGINATION? If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Senior Director, GxP Quality Live What you
Posted 7 days ago | Updated 6 hours ago

GxP Business Analyst

Spotline

•

Remote

Full-time

Position: - GxP Business Analyst Duration :- Long term contract / Fulltime Location:- Fully Remote (EST work hours) Rate / Salary :- OPEN Recent experience working in a GxP Pharma or Medical Devices environment is a must have. Seeking LIMS, eTMF, Veeva Vault, V model, Agile, CTMS experience Skills Preferred: Delivering significant business results that utilize strategic and creative thinking, problem solving, and taking individual initiative.Strong GXP knowledge is required.Familiarity with Gx
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Posted 9 days ago

Business Analyst (Immediate Role)

Xoriant Corporation

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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 17 days ago | Updated 15 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 23 days ago | Updated 10 days ago

Computer System Validaiton Consultant

Kellton

•

Remote

Contract

Computer System Validaiton Consultant Hazelwood, MO (100% Remote) 12 months with possible extension or conversion Max PR- $54/hr on W2 Job Summary: As a Computer Systems Validation Consultant, you will play a critical role in interpreting and enforcing relevant GxP regulations and standards, ensuring consistent application across global GxP IT systems. Your responsibilities will include managing periodic reviews, providing oversight for non-GxP changes, authoring/reviewing technical documents, a
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Posted 2 days ago | Updated 1 day ago

CSV Lead

Ventures Unlimited

•

Indianapolis, Indiana, USA

Full-time

Role:: CSV Lead. Location: Indianapolis, IN. Fulltime/ Permanent. Skill Sets:. Conduct validation assessments for computer systems, software applications, and electronic records in compliance with healthcare regulatory requirements.Develop and execute validation protocols, test scripts, and validation plans for computer systems used in the healthcare industry.Collaborate with cross-functional teams, including IT, Quality Assurance, and Regulatory Affairs, to ensure alignment with validation requ
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Posted 9 days ago | Updated 2 days 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 16 days ago | Updated 21 hours ago

Great Plains ERP Techno Functional Consultant

Tekniforce

•

Cary, North Carolina, USA

Full-time

We are looking for a Great Plains ERP Techno Functional Consultant. This is an on-site fulltime permanent hire position in Cary (RTP), NC. In this role you will be supporting Great Plains Enterprise Resource Planning (ERP), interfaces and systems including configuration, customization, security, data integrity and on-going support for all functional areas. You will lead the configuration and maintenance of value-added solutions to meet the defined requirements and reporting needs of the busines
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Posted 7 days ago | Updated 3 days 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 11 days ago | Updated moments 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 22 days ago | Updated 21 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 39 days ago | Updated 16 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 23 days ago | Updated 2 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 23 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 18 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 22 days ago

Data Stewardship and Compliance Business Analyst-Hybrid

FORTIRA INC.

•

Seattle, Washington, USA

Contract

Job Description Job Title: The Data Stewardship and Compliance Business Analyst Location: Seattle-Dexter, WA*Hybrid Top Skills: Demonstrated experience in coordinating with cross-functional and site teams to ensure accurate and timely compilation of data. Ability to manage project timelines, prioritize tasks, and handle multiple projects simultaneously.Demonstrated proficiency in MS Project, PowerPoint, Excel, Word, and Document Managements Systems (Veeva Vault preferred).Experience in data anal
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Posted 9 days ago

Sr. Medical Affairs Systems Engineer

SPECTRAFORCE TECHNOLOGIES Inc.

•

Santa Monica, California, USA

Contract

Job Title: Sr. Medical Affairs Systems Engineer Location: Santa Monica, CA or Raleigh, NC (Hybrid - 3 days/week onsite) Duration: 6+ Months About Role: We are seeking a highly motivated Sr. Analyst to support Medical Affairs on their digital technology needs. You will work with the Information Technology team in supporting our efforts in this exciting new area of cell therapy. This role will work closely with the Medical Affairs functions to deliver technology solutions that meet our critical bu
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Posted 9 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 19 hours ago | Updated 7 hours 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 15 days ago | Updated 2 days ago