Jobs at QRC Group, LLC

Support AI-enabled optimization, resource planning, workload modeling, capacity evaluation, process improvement, and validation initiatives in pharmaceutical manufacturing. Collaborate cross-functionally to apply data analytics, digital solutions, and operational insights to improve performance, ensure GMP-compliant processes, and enable data-driven decisions.

Support commercial biopharmaceutical manufacturing with emphasis on formulation and aseptic filling. Monitor processes, troubleshoot issues, lead investigations and root-cause analysis, drive continuous improvements, ensure GMP/regulatory compliance, prepare inspection documentation, and collaborate cross-functionally while supporting floor operations and variable shifts.

Support quality and compliance in a regulated biopharmaceutical manufacturing environment by ensuring regulatory compliance, validation and audit support, reviewing critical quality documentation, approving deviations and trend reports, and driving continuous improvement to maintain inspection readiness.

Support equipment and system decommissioning in a regulated manufacturing environment, manage technical documentation, execute impact assessments, ensure regulatory compliance, coordinate cross-functional teams, drive continuous improvement, and manage projects to meet deadlines.

Support and maintain GMP-compliant quality systems in a regulated manufacturing setting. Review/manage quality documentation, participate in investigations and CAPAs, provide manufacturing quality support, and collaborate cross-functionally to ensure products and processes meet regulatory and company standards.

Lead characterization and optimization of manufacturing equipment and processes. Own CMMS activities, improve reliability and availability, reduce downtime, develop performance metrics, lead equipment improvement projects, act as SME for design/maintenance, support troubleshooting, manage CAPAs and deviations, and drive EHS compliance.

Designs, implements, and executes scientific experiments to support process development projects under supervision. Works on drug product manufacturing, process validation, and authors technical protocols and reports. Collaborates cross-functionally and applies engineering principles when relevant.

Support scientific and technical activities in a regulated manufacturing environment. Lead process development and improvement efforts, execute and document validation (including filling validation), produce technical documentation, and ensure compliance with regulatory requirements. Collaborate cross-functionally to drive process robustness and validation-ready processes.

Lead aseptic sterile drug product process development, validation (PPQ), technology transfer, and commercial support. Perform statistical analysis (JMP/Minitab), author validation/technical reports, drive contamination control and GMP compliance, and coordinate cross-functional teams to enable manufacturing readiness and continuous process improvement.

Support process engineering for pharmaceutical manufacturing recapitalization, BCP, equipment lifecycle, capital projects, commissioning/qualification, validations, CAPA, investigations, and continuous improvement while ensuring quality, safety, and environmental compliance.

Lead engineering initiatives for equipment development, process improvement, validation, and project execution in a regulated manufacturing environment. Support packaging equipment design and operations, ensure quality and regulatory compliance, and manage engineering projects within medical device or pharmaceutical settings.

Support and maintain GMP environmental monitoring and critical utilities programs. Generate trend reports, lead risk assessments, support change control/deviations/audits, present findings to management, and drive continuous improvement to ensure compliance with Annex 1, FDA, ISO and USP standards.

Lead change control and deviation investigations across the manufacturing lifecycle, perform root cause analyses and CAPA, support risk and microbial assessments, readiness for commercial campaigns, and author technical protocols and MBRs. Owner of manufacturing procedures and documentation, support floor troubleshooting, training, and process improvement initiatives, and collaborate cross-functionally during process/equipment changes and regulatory inspections.

Provide on-site SAP SME support for implementation, validation (IQ/OQ/PQ) and go-live in a regulated medical device manufacturing environment. Lead UAT, hypercare support, training, compliant documentation (WIs, SOPs), ensure FDA/ISO compliance, troubleshoot SAP transactions and master data, and recommend process improvements for post-go-live optimization.

Support biotechnology/pharmaceutical drug substance processes and GMP manufacturing systems. Provide process engineering support, technical writing, and use SAP, TrackWise, PAS/X, and Veeva. Bilingual Spanish/English required.

Manage and execute facilities and utilities engineering projects, coordinating contractors and internal teams to deliver designs, installations, commissioning, and qualification. Monitor timelines, budgets, and compliance with safety, environmental, and regulatory standards (e.g., GMP). Drive continuous improvement and maintain technical documentation and project plans.

Lead process optimization, troubleshooting, and major system modifications for manufacturing/pilot plant operations. Design and implement experiments and capital projects, analyze results, improve equipment reliability, and coordinate cross-functional teams including mechanics, automation, IS, quality, and validation.