gamp Jobs in north carolina

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Computer System Validation Lead

Nityo Infotech Corporation

•

Remote

Third Party, Contract

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 validation like ServiceNOW, Automation tools, JIRA Gu
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Posted 4 days ago

Quality Assurance Specialist (Two openings)

Johnson and Johnson

•

Wilson, North Carolina, USA

Full-time

Job DescriptionAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for hu
Posted 2 days ago | Updated 5 hours ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

•

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 19 days ago | Updated 7 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 7 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 13 days ago | Updated 5 days ago

Payroll Accounting Consultant

Grepforce LLC

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Remote

Contract

What we look for: Bachelor's degree in Accounting, Finance, or related field.5+ years of general ledger and payroll accounting experience.Strong understanding of GAAP and payroll accounting practices.Proficiency in Excel and experience with ERP systems (e.g., NetSuite, Workday, SAP).Strong attention to detail and analytical skills.Excellent organizational and communication skills.Proven ability to work independently and meet deadlines in a dynamic environment.CPA preferredExperience in a high-gr
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Posted 11 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 17 hours ago | Updated moments ago

Certified Ophthalmic Technician

Duke Health

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Holly Springs, North Carolina, USA

Full-time

Job DescriptionAt Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together. Duke Health Integrated Practice Pursue your passion for caring with Duke Health Integrated Practice, which comprises more than 110 primary and specialty outpatient clinics, extending the reach of Duke Health's mission across the state of North Ca
Posted 4 days ago | Updated 5 hours ago

Tagetik Technical Support

OnwardPath Technology Solutions LLC

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Remote

Contract

Finance/Accounting Degree preferred, and/or at least 10 years in accounting (focus in Financial Closing and Consolidation required; exposure to Foreign Currency is preferred)Deep understanding of the Tagetik architecture and modules (Financial Close, Budgeting & Planning, IFRS/GAAP Consolidation, Financial Reporting).Experience in configuring and customizing Tagetik solutionsExperience with SDLC (System Design Life Cycle) and deployment in Tagetik projects
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Posted 20 days ago | Updated 2 hours ago

Certified Ophthalmic Assistant

Duke Health

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Durham, North Carolina, USA

Full-time

Job DescriptionAt Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together. Duke Health Integrated Practice Duke Health Integrated Practice comprises more than 110 primary and specialty outpatient clinics, extending the reach of Duke Health's mission across the state of North Carolina. $5,000 Commitment Bonus for qualify
Posted 4 days ago | Updated 5 hours ago

Engineer II, Quality

Thermo Fisher Scientific

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Asheville, North Carolina, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Job Description Join Thermo Fisher Scientific Inc. as an Engineer II, Quality in Asheville, and be part of an exceptionally dedicated team! We are a company that thrives on innovation and collaboration, and we are looking for an ambitious individual who is ready to contribute to our world-class projects. This is an outstanding opportunity to work in an environ
Posted 32 days ago | Updated 7 hours 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 58 days ago | Updated 7 hours ago

C&Q Engineer

Sunrise Systems, Inc.

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Wilson, North Carolina, USA

Contract

Job Title: C&Q Engineer Job ID: 25-09377 Location: Wilson, NC 27893 Duration: 17 Months On W2 Contract Job Purpose The C&Q Engineer is responsible for the execution of the defined C&Q scope of the following areas Black Utilities and HVAC. These are Client-side roles and key responsibilities are meeting the agreed objectives regarding time, schedule and functionality according to EHS, URS and GMP requirements. The C&Q Engineer SME is responsible for planning and executing commissioning activit
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Posted 4 days ago | Updated 3 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 17 days ago | Updated 7 hours ago

Manager 2 - Process Engineering

Katalyst Healthcares and Lifesciences

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Wilson, North Carolina, USA

Full-time

Responsibilities: Strong technical background in Process and Manufacturing engineering, manufacturing operations and financial fundamentals. Strong analytical skills to synthesize business needs, manufacturing requirements, engineering elements, and technology inputs, etc. into business solutions. The ability to lead and/or support multiple projects simultaneously. Defines technical or scientific direction of programs composed of multiple complex projects. Engineers new and modify existing proc
Posted 60+ days ago | Updated 7 hours ago

Manager 2 - Process Engineering

Katalyst Healthcares and Lifesciences

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Jacksonville, North Carolina, USA

Full-time

Responsibilities: minimum of eight (8) years of process/plant engineering experience in GMP MFG large molecule biologics facilities. Experience in green or brown field GMP MFG facility start-up including process systems, automation, utilities, facilities and operations. Strong technical background in Process and Manufacturing engineering, manufacturing operations and financial fundamentals. Strong analytical skills to synthesize business needs, manufacturing requirements, engineering elements, a
Posted 60+ days ago | Updated 7 hours ago

Quality Engineer

Judge Group, Inc.

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Charlotte, North Carolina, USA

Contract

Location: Charlotte, NC Salary: $90,000.00 USD Annually - $120,000.00 USD Annually Description: QUALITY ENGINEER (Must have experience in manufacturing) Job Summary: Our client, a plastics and packaging manufacturer, is seeking a Quality Engineer to lead quality assurance efforts, ensure compliance with industry standards, and support continuous improvement across operations. Responsibilities: Act as the plant expert for quality systems and initiatives Standardize quality operations to redu
Posted 16 hours ago | Updated 4 hours ago

Finance Analyst ONLY W2

Aziro Technologies LLC

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Remote

Contract

SKILLS NEEDED Excellent understanding of US GAAP, revenue recognition, and financial analysis, with advanced knowledge in Profit and LossExcellent analytical skillsExcellent business application skills (e.g., Microsoft Excel). Must be able to make pivot tables, analyse revenue, costs, apply procedures, determine actions to be taken and prepare summary reports.Knowledge of SAP ERP, booking manual Journal Entries, Intercompany Billings is mandatorySuperior communication and influencing skills, sho
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Posted 12 days ago

Principal Process Engineer

Katalyst Healthcares and Lifesciences

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Wilson, North Carolina, USA

Full-time

Job Description: We are seeking a Principal Process Engineer with a strong background in GMP manufacturing and engineering. The ideal candidate will have hands-on experience in biologics, process systems, automation, and utilities with a focus on upstream and/or downstream processes. The role will be initially remote and then onsite in Wilson , NC, once the facility opens. Responsibilities: Provide technical leadership in GMP large molecule biologics manufacturing. Engineer and modify proce
Posted 52 days ago | Updated 7 hours ago

Field Service Engineer I (lab equipment)

Thermo Fisher Scientific

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Colorado, USA

Full-time

Work Schedule Other Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps hot/cold, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Field Service Engineer (lab equipment) When you join us at Thermo Fisher Scientific, you'll be part of an inquis
Posted 11 days ago | Updated 7 hours ago