gamp Jobs in new jersey

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DeltaV Automation Engineer

Fynbosys Inc

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Remote or Muskegon, Michigan, USA

Contract

Title : Sr/Lead DeltaV Automation Engineer Location - Muskegon, MI (Onsite) Cognizant JD : This is a remote position open to any qualified applicant in the United States.We are open to considering remote candidates who are willing to travel frequently to client sites at Muskegon MI. Travel Requirement : The travel requirements include an initial three weeks to overlap with another senior engineer. Subsequently, the schedule is anticipated to be two weeks of travel to Muskegon MI followed by thr
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Posted 2 days ago

compliance lead

Adva IT Services, Inc..

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Remote

Contract

Key Responsibilities Lead the design and execution of the company s compliance framework, covering GxP areas (GMP, Google Cloud Platform, GLP) and validated system lifecycle activities. Ensure compliance with SDLC processes for GxP-relevant computerized systems, including documentation, validation, change control, and audit readiness. Develop and maintain SOPs and training programs related to software/system validation and data integrity (e.g., per 21 CFR Part 11 and Annex 11). Provide complianc
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Posted 2 days ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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Raritan, New Jersey, USA

Full-time

Roles & Responsibilities: 7-10 years' experience in Computer System Validation of SAAS systems, and Cloud systems. Must have experience in Agile methodology and handled multiple releases in parallel. Has working experience in any one or two of the following domains Tool validation like Service Now, Automation tools, JIRA. Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC. Application of FDA guidance's a
Posted 7 days ago | Updated 4 hours ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

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Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's
Posted 23 days ago | Updated 4 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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New Brunswick, New Jersey, USA

Full-time

Job description: We're seeking a Senior MES Engineer/Validation Lead to take ownership of computer system validation activities for Manufacturing Execution Systems (MES) supporting cell therapy manufacturing. This role is ideal for someone with a strong IT/Computer Science foundation and 3 years of hands-on experience in the pharma/biotech industry. You'll partner with QA, Business, and IT teams to ensure compliant and efficient deployment of MES & Recipes solutions. Responsibilities: Lead end
Posted 60+ days ago | Updated 4 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana
Posted 60+ days ago | Updated 4 hours ago

SAP Finance FICO Consultant

URSI Technologies Inc.

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Remote

Contract

SAP Finance FICO Consultant San Francisco, CA Remote Remote Qualifications The ideal candidate will have hands-on experience in SAP S4HANA and ECC, a strong understanding of GAMP 5, cGMP, and SOX compliance requirements, and proven application support skillsKey Responsibilities: Provide application support for SAP FICO modules within a regulated IT environmentTranslate business requirements into SAP solutions using SAP Best Practices, FIORI apps, and embedded analyticsJob description : 9+ to 15
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Posted 18 days ago | Updated 10 days ago

CSV Lead

Prudent Technologies and Consulting

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Raritan, New Jersey, USA

Third Party, Contract

Role - CSV Lead Location - Raritan, NJ(Hybrid) Job Details: 7-10 years experience in Computer System Validation of EMS and BMS applications Must have experience in Agile methodology and handled multiple releases in parallel Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation, experience with EMS/BMS, project management, test script review, test execution review, test defect management. Has working experience in any one or two of the following domains Tool val
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Posted 8 days ago

AP/AR & Invoicing Accounting Specialist - Ridgewood, NJ - 2 day a week

MetaSense, Inc.

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Ridgewood, New Jersey, USA

Full-time

Employment Type: Part-Time 23-30 Hours Week Company Overview: We are seeking a skilled and detail-oriented Accounting Specialist to manage invoicing, accounts payable (AP), and accounts receivable (AR) functions. This role is critical to maintaining accurate financial records and ensuring smooth day-to-day accounting operations. Key Responsibilities: Invoicing & Revenue Tracking Generate and send tenant rent invoices, lease charges, and other billablesTrack incoming payments and apply to the cor
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Posted 3 days ago | Updated 1 day ago

Infrastructure Business Analyst

TEKsystems c/o Allegis Group

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Branchburg, New Jersey, USA

Full-time

Description We are seeking a skilled and motivated Infrastructure Business Analyst to support IT initiatives within a regulated manufacturing environment in Branchburg, NJ. This role is ideal for professionals with a background in business analysis or project coordination, particularly within GMP-compliant pharmaceutical or manufacturing settings. You will play a key role in bridging the gap between IT infrastructure and operational technology (OT), ensuring seamless integration and compliance.
Posted 7 days ago | Updated moments ago

Manager, Commercial IT Systems

Garshan Associates

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Florham Park, New Jersey, USA

Full-time

Manager, Commercial IT Systems Florham Park, NJ $120,000 - $150,000 The Manager, Commercial IT Systems will be responsible for effective provisioning, operation, installation/configuration and maintenance of web applications for the Commercial business users. The incumbent will evaluate digital solutions such as marketing platforms, websites and sales applications, and provide technical support, guidance and hands-on delivery in the planning, implementation, and ongoing operation of Commercial
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Posted 31 days ago | Updated 3 days ago

Project Manager - Gxp

Oraapps Inc

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Remote

Contract

Job Title -Project Manager Gxp Location - Remote Contract Duration - 6+ Months Requirement: - 8+ years full lifecycle PM experience - Demonstrated PMLC/SDLC experience/success - Ability to quickly adapt to a maturing project environment - Ability to manage multiple concurrent priorities - MS Project and the ability to execute project plan is a must have MUST BE STRONG MS PROJECT - GXP & GMP Experience - Heavy experience required Plus: - GMP project experience, preferably as a PM - PMP certific
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Posted 2 days ago | Updated 1 day ago

Accounting Specialist (AP/AR & Invoicing)

MetaSense, Inc.

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Ridgewood, New Jersey, USA

Part-time

Company Overview: We are seeking a skilled and detail-oriented Accounting Specialist to manage invoicing, accounts payable (AP), and accounts receivable (AR) functions. This role is critical to maintaining accurate financial records and ensuring smooth day-to-day accounting operations. Key Responsibilities: Invoicing & Revenue Tracking Generate and send tenant rent invoices, lease charges, and other billablesTrack incoming payments and apply to the correct accountsCoordinate with property manage
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Posted 3 days ago

Full stack Developer-LAMP

Akshaya Inc

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Remote

Third Party, Contract

Job Title :LAMP Full stack Developer Location: Remote Experience: 15+Years Required Description: Lead efforts to build and migrate features from the current LAMP stack application to Google Cloud using state of the art techstack using NodeJs, VueJS, CloudSQL and Google Cloud technologies. Deep knowledge building full stack apps using VueJS, NodeJS, HTML5, CSS3, JavaScript and microservices. Working knowledge of PHP applications and ideally have experience migrating them.
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Posted 3 days ago

Raw Materials Technical Specialist

Aditi Consulting

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Remote or Cambridge, Massachusetts, USA

Contract

Payrate: $38.00 - $40.00/hr. Summary: The ideal candidate will have a strong background in documentation and regulatory specification development within a GMP-compliant environment. They should bring experience in project management and raw material specification, ideally from pharmaceutical, biotech, or similarly regulated industries (such as aerospace or chemical engineering). The role is fully remote and requires someone who can work independently with minimal supervision while contributing t
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Posted 5 days ago | Updated moments ago

Broker Dealer Regulatory Reporting Controller

MDMS Recruiting

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Jersey City, New Jersey, USA

Full-time

NO SPONSORSHIPW-2 ONLYHYBRID - need to be local to Jersey City, NJ Our Direct Client is seeking a Broker Dealer Regulatory Reporting Controller in Jersey City, NJ (Hybrid) for an FTE role. Analytical skills in order to be able to give an independent and relevant opinion on the control framework or the correct application of regulations on broker dealer operations.Strong audit skills and good knowledge of SEC and Finra regulationsProduct knowledge in Broker Dealers derivatives, loans, funding ve
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Posted 22 days ago | Updated 2 days ago

Data Integrity Manager

HAYS

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Princeton, New Jersey, USA

Contract

Data Integrity Manager - Contract - Princeton, NJ/Hybrid - $64.77 - $64.77/hr. The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position. Applicants must be legally authorized to work in the United States. Sponsorship not available. Our client is
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Posted 52 days ago | Updated moments ago

Finance Manager

First Tek, Inc.

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Piscataway, New Jersey, USA

Full-time

Job Summary: Manages daily, weekly, and/or monthly financial reporting; leads monthly financial statement preparation; supervises year-end audit and tax preparation for external CPA; assist with special projects as assigned; approve work prepared by domestic and offshore accounting staff; Performs complex reconciliations and financial analysis, interpretation, and reporting. Roles & Responsibilities: Perform and supervise monthly financial closing procedures and compliance with appropriate GAAP
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Posted 24 days ago | Updated 9 days ago

Process Engineer

Katalyst Healthcares and Lifesciences

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Remote or New York, USA

Full-time

Responsibilities: Senior Process Engineer responsible for tech transfers within the manufacturing team. Support GMP-related activities. Experience in tech transfer and project management. Strong technical skills, including report writing and problem-solving. Excellent communication skills, with the ability to clearly relay technical information. Cell Therapy (CAR-T) experience (preferred). Willingness to travel (approximately 25%). t least 5 years of relevant experience.
Posted 60+ days ago | Updated 4 hours ago

Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, Inc.

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Remote or Foster City, California, USA

Full-time

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro
Posted 21 days ago | Updated 4 hours ago