Jobs at QRC Group, LLC

Provides engineering support for daily manufacturing operations through troubleshooting, process optimization, equipment and system modifications, upgrades, and replacements. Collaborates with manufacturing, maintenance, quality, validation, utilities, and facilities teams. Supports deviations, equipment qualification, process validation, procedures, training, new product introductions, experiments, and capital projects. Monitors operational performance, recommends solutions, and provides technical mentorship. Requires support for 24/7 non-standard shifts, including extended hours and weekends.

Supports packaging equipment and production processes in a GMP-regulated environment. Responsibilities include process characterization, validation, monitoring, optimization, CAPA management, technical report writing, statistical analysis, DOE, root cause investigations, and resolving production issues. Requires flexibility to work first- or second-shift schedules, including nights, weekends, holidays, and extended hours.

Supports commercial pharmaceutical and biotechnology manufacturing operations, with emphasis on sterile injectables, drug-device combination products, packaging, labeling, troubleshooting, investigations, process validation, and GMP quality systems. Leads projects, authors technical documentation, analyzes process performance, supports improvements and technology transfers, and provides on-floor technical guidance. Collaborates with Manufacturing, Quality, Engineering, Validation, Maintenance, Automation, Supply Chain, and Regulatory teams. Requires an engineering degree, relevant experience, and full English-Spanish bilingual proficiency.

The Senior Specialist QA will support commissioning and qualification, equipment validation, quality risk assessments, change controls, SOPs, and Good Documentation Practices. The role requires substantial directly related experience based on education level and bilingual English and Spanish proficiency.

Supports SAP implementation, validation, testing, go-live, hypercare, and user adoption within a regulated medical device manufacturing environment. Provides SAP module expertise, troubleshoots transactions and workflows, develops compliant documentation and training, coordinates with IT and SAP partners, and ensures alignment with FDA, ISO 13485, data integrity, and audit requirements. Identifies process gaps and supports post-go-live optimization.

Leads pharmaceutical quality assurance activities including facilities and utilities commissioning and qualification, computer system and equipment validation, risk assessments, change controls, SOPs, documentation review, data integrity, and syringe/vial inspection processes. Uses KNEAT, CDOCS, SCADA, TrackWise, and Maximo. Requires bilingual Spanish and English communication and substantial directly related experience based on education level.

Process Engineer supporting pharmaceutical and medical device manufacturing operations. Responsibilities include validation lifecycle activities, root cause analysis, QN and CAPA investigations and closures, and support for manual and automated production systems. The role requires a bachelor’s degree in engineering, medical device experience, bilingual English and Spanish skills, and flexibility to support 24/7 operations, including shifts, weekends, and holidays, in Texas.

Provide technical Quality Assurance leadership across manufacturing and site quality programs. Responsibilities include approving process validation, environmental characterization, sanitary utility release, planned incidents, and product documentation; leading investigations; participating in incident triage and new product introduction teams; and owning quality procedures. The role requires expertise in commissioning and qualification, computer and equipment validation, risk management, data integrity, change controls, documentation practices, and regulated pharmaceutical inspection processes.

Develops practical digital tools, dashboards, and process improvements to address ambiguous operational challenges. Supports drug product manufacturing, characterization studies, engineering runs, PPQ, validation deliverables, and manufacturing readiness. The role may involve data analysis, statistical evaluation, GMP documentation, validation principles, automation tools, and collaboration across manufacturing activities. English and Spanish bilingual proficiency is preferred.

Enters recipes into packaging equipment, assesses automation requirements, and determines appropriate recipe parameters using the Systech System. Requires a bachelor’s or master’s degree, two years of engineering experience, and bilingual Spanish-English proficiency.

Supports sterile drug product manufacturing through aseptic processing, process characterization, validation, technology transfer, and commercial process support. Analyzes manufacturing data, authors validation and technical documentation, leads investigations and change controls, and drives continuous process improvement. Collaborates with Manufacturing, Quality, Engineering, Regulatory, and Technical Services teams while providing scientific leadership and managing multiple projects in a GMP environment.

Supports facilities and engineering quality systems in a regulated manufacturing environment. Responsibilities include investigating deviations, managing CAPAs and change controls, maintaining controlled documentation, supporting OEFM electronic forms, coordinating pest control programs, and ensuring records remain compliant and inspection-ready. The role collaborates with Quality, Facilities and Engineering, vendors, and other stakeholders while supporting FDA and regulatory requirements.

Leads training compliance and qualification programs within a regulated medical device manufacturing environment. Develops compliant curricula, oversees training records and LMS processes, monitors completion and effectiveness metrics, supports remediation and audit readiness, and collaborates with Quality, Operations, Regulatory Affairs, Engineering, and project teams. Drives continuous improvement, governance, documentation compliance, and corrective actions while presenting compliance dashboards and reports to stakeholders.

Supports QMS remediation, corrective actions, controlled documentation, regulatory compliance, audit readiness, change requests, complaint monitoring, and deviation management. Collaborates cross-functionally to harmonize procedures, improve quality processes, track remediation progress, and support internal, supplier, customer, FDA, notified body, and MDSAP audits in a regulated life sciences environment.

Manage facilities and utilities capital projects from design through commissioning, coordinating contractors, vendors, and internal teams. Monitor budgets, schedules, and performance metrics while ensuring safety, environmental, regulatory, and applicable GMP compliance. Support technical documentation, qualification activities, maintenance improvements, operational reliability, and continuous improvement initiatives.