Jobs at QRC Group, LLC

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.

Lead manufacturing quality investigations for sterile and non-sterile operations, ensuring timely closure of quality events, NTRs, and NOEs. Coordinate investigation information, develop recurrence-prevention actions, evaluate QE and CAPA trends, support regulatory submissions and inspections, and contribute to site initiatives. The role requires scientific and compliance expertise, statistical data analysis, technical writing, and bilingual Spanish-English communication.

Develop and execute commissioning and qualification strategies for pharmaceutical or medical device systems. Lead risk assessments, FAT, SAT, field commissioning, IQ/OQ/PQ protocols, characterization activities, documentation, change controls, deviations, and CAPA. Ensure compliance with GMP, FDA, EMA, data integrity, and ALCOA+ requirements. Coordinate with engineering, validation, quality, manufacturing, supply chain, vendors, and system owners while mentoring junior engineers.

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.

Performs plant quality assurance oversight for cGMP manufacturing, batch records, testing, deviations, CAPAs, validations, change control, audits, and inspections. Partners cross-functionally on quality systems, manufacturing, process development, NPI, and compliance risks. Requires expertise in commissioning and qualification, GxP application validation, computer systems validation, quality systems, regulatory interaction, data trending, and bilingual English-Spanish communication.

Provides quality assurance oversight to ensure compliance with regulatory requirements, internal quality standards, and site procedures. Collaborates with Manufacturing, Engineering, Facilities, Validation, and Operations teams while working with minimal supervision. Responsibilities require experience with change control, documentation review, validation, and process performance qualification (PPQ), along with full English and Spanish bilingual proficiency.

Supports QMS remediation and corrective actions in a regulated medical device or life sciences environment. Maintains controlled procedures, work instructions, forms, and templates; monitors remediation progress; supports continuous improvement, change control, complaint monitoring, and deviation management. Assists with internal, supplier, customer, FDA, Notified Body, and MDSAP audits while maintaining audit readiness and regulatory compliance with ISO 13485, FDA QMSR, EU MDR, and company procedures.

Support daily manufacturing operations for medical device and pharma processes, including validation lifecycle (design/execute/analyze/close), root cause analysis, investigations and QN/CAPA closures, and working with manual and automated production lines. Provide operational support across shifts in a fast-paced, 24/7 site in Texas. Bilingual (English/Spanish) required.

Provide engineering support for GMP-regulated manufacturing: troubleshoot equipment and processes, supervise production performance, support deviations, equipment qualification, process validation, cross-functional improvements, documentation, and new product introductions while working non-standard shifts.

Design, implement, and maintain manufacturing automation systems; apply engineering principles to system modifications, experiments, processes, and capital projects. Work with PLC programming, HMIs, conveyors, and molding machines; perform troubleshooting and produce technical documentation.

Manage and store retained raw material, bulk, and finished goods samples under specified conditions; document traceability; perform visual inspections and report findings; track inventory and expirations; dispose of expired samples per regulations; and support investigations by gathering and reviewing evidence. Role requires bilingual communication and reporting.

Provide engineering support for process optimization, troubleshooting, and operational improvements in manufacturing and pilot plant environments. Evaluate systems, implement modifications, analyze data, and support regulatory compliance, validation, and capital projects. Collaborate with manufacturing, quality, maintenance, and engineering teams to improve equipment and system performance.

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.