Teams at QRC Group, LLC

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.