150 applicants

Company

Spotline, Inc. · 1 day ago

Software Architect

United States

Full-time

Remote

Mid Level

$100/hr - $100/hr

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Responsibilities

Implement & configure

Scispot for Laboratory Information Management Systems (LIMS) and Customer Portal implementation

Compliance Quest for Quality Management Systems (QMS)

Ensure GxP Compliance

Prepare and execute validation plan, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols to verify that the systems meet intended specifications and regulatory requirements.

Prepare and maintain all other necessary validation documentation, reports, and supporting SOPs to ensure comprehensive regulatory compliance.

This role is integral in deploying, validating, and supporting these systems to enhance lab management, customer engagement, and regulatory compliance.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

LIMS implementationGxP complianceValidation processesScispotQuality Management SystemCAPADocument controlAudit managementRisk assessmentLabWareSTARLIMSMasterControlVeeva

Required

Bachelor’s degree in Life Sciences, IT, or a related field (scientific or engineering discipline)

Proven experience in implementing and supporting LIMS in a GxP regulated environment

Strong understanding of LIMS functionality, including sample tracking, data capture, workflow automation, and lab reporting (with any LIMS product)

Experience in configuration & troubleshooting as part of LIMS implementations (any LIMS product)

Deep expertise including configuration, customization and integration with at least one LIMS product (LabWare, STARLIMS, Scispot etc)

Experience with the GxP compliant validation process

Experience with Scispot for LIMS and Scispot for Customer Portal

Preferred

Experience with implementation of a Quality Management System Compliance (QMS) with any QMS product (Compliance Quest, MasterControl, Veeva)

Expertise in QMS processes, such as CAPA (Corrective and Preventive Actions), document control, audit management, and risk assessment

Experience with Compliance Quest for QMS

Experience with GxP based validation process & knowledge of Validation Plans, IQ, OQ, PQ creation & execution

Benefits

401(k)

Dental insurance

Health insurance

Company

Spotline, Inc.

At Spotline, we stand at the cutting-edge of the Life Sciences industry, championing the next wave of digital transformation with our advanced AI and Automation technologies.

Founded in 2015

San Jose, California, USA

51-200 employees

https://spotline.com/

H1B Sponsorship

Spotline, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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Trends of Total Sponsorships

2023 (5)

2022 (4)

2021 (5)

2020 (8)