Part 11 Jobs

Experienced QA-focused scientist needed to perform GMP/GLP audits, review analytical data and batch records, and support quality systems at Eurofins' San Diego lab.

Celerion seeks an experienced Clinical Data Manager in Tempe, AZ to manage clinical database setup, cleaning, query resolution, and sponsor-facing data management activities across early- to late-phase studies.

Care Access Research is hiring a Source Document Specialist to design, maintain, and version-control compliant eSource and paper source documents for remote clinical trial operations.

Experienced platform-focused IT engineer needed to deploy, operate, and support IT infrastructure at FUJIFILM's new Holly Springs biomanufacturing site while aligning with global IT architecture and regulated compliance.

QRC Group seeks an experienced Quality Systems Specialist to manage and improve quality systems, support investigations, and ensure compliance with GMP, FDA 21 CFR Part 11 and data integrity requirements.

Statistics & Data Corporation is hiring a Principal Clinical Programmer to lead EDC database development, validation, and integrations while serving as a technical SME and mentor for clinical programming teams.

AbbVie's Waco site is hiring a Senior Automation Engineer to lead design, validation, and lifecycle management of manufacturing control systems to enhance productivity, quality, and safety.

Experienced STARLIMS developer needed to lead configuration, integration, and compliance-focused development of STARLIMS v12+ for a healthcare-focused, regulatory-driven environment.

Experienced healthcare IT product analyst needed to drive requirements, design, and delivery of financial and clinical research solutions for SCRI, supporting oncology clinical trials and enterprise users.

Lead the implementation and validation of Emerson DeltaV control systems for regulated biopharma and medical device manufacturing at an employee-owned engineering company based in Kalamazoo, MI.

Abbott's Lingo division is hiring a Quality Engineer II to lead design control, CAPA, and risk-management activities for medical devices and SaMD from our Alameda, CA site.

Lead CPC's technology modernization as Managing Director of Technology, driving secure, compliant, and data-enabled transformation across the organization.

Abbott seeks a Senior Design Control Software Quality Engineer to validate and maintain Lingo product software and computerized quality systems in compliance with medical device regulations.

Abbott is hiring a Software Quality Engineer II in Sylmar, CA to lead software validation, quality engineering, and regulatory compliance for non-product medical device software.

Experienced IT professional needed to deliver onsite L2/L3 support for lab instrument PCs and applications in a regulated pharmaceutical/biotech setting.

Lead the design and operationalization of scalable lab and enterprise data architectures to enable scientific insights and regulatory-compliant data management across AskBio's global lab network.

AbbVie is hiring an IT Technical Specialist to lead and support Quality Labs application projects and integrations that improve lab productivity and regulatory compliance.