Teams at Quality Consulting Group

Performs plant quality assurance review and approval of cGMP manufacturing processes, records, testing, deviations, CAPAs, change controls, validations, and quality systems. Supports audits, inspections, commissioning, qualification, NPI, risk assessments, and continuous improvement initiatives. Collaborates with manufacturing, engineering, validation, quality control, facilities, and other cross-functional teams to maintain compliance, assess quality risks, and resolve quality events.

Provides engineering support for pharmaceutical and biotech manufacturing operations, including troubleshooting, process optimization, equipment upgrades, system modifications, validation, qualification, deviations, and capital projects. Ensures GMP and regulatory compliance while collaborating with Manufacturing, Maintenance, Quality, Validation, Facilities, Utilities, and Process Development teams. Monitors performance, recommends improvements, mentors personnel, and supports 24/7 operations, including nights, weekends, extended hours, and non-standard shifts.

Performs plant quality assurance review and approval of cGMP manufacturing processes, batch records, testing methods, deviations, CAPAs, change controls, validations, and quality systems. Supports audits, regulatory inspections, commissioning, qualification, GxP validation, NPI, quality investigations, data trending, and continuous improvement. Collaborates with manufacturing, validation, engineering, quality control, and other cross-functional teams while communicating compliance and operational risks.