Jobs at Quality Consulting Group

Supports pharmaceutical and biotech facilities engineering and quality systems. Manages deviations, CAPAs, change controls, documentation, electronic forms, pest control programs, and inspection readiness. Provides technical expertise for HVAC, chilled water, and cooling tower systems, including preventive and predictive maintenance optimization and troubleshooting. Coordinates engineering projects, consultants, architects, and design documentation while driving compliance, problem solving, and continuous improvement.

Leads strategic and complex New Product Introduction programs from planning through execution, commercialization, and operational readiness. Manages project scope, budgets, timelines, resources, governance, risks, regulatory compliance, change control, and cross-functional stakeholder alignment. Develops project strategies, maintains master plans, supports process improvements, prepares reports and presentations, and provides strategic leadership to project teams in pharmaceutical, biotech, medical device, and manufacturing environments.

Leads manufacturing equipment relocation, installation, commissioning, validation, change management, and decommissioning in regulated manufacturing environments. Designs production processes, facility layouts, operating sequences, and equipment specifications; evaluates machinery performance and resolves deficiencies. Supports IQ/OQ/PQ, CSV, process and cleaning validation, cleanroom qualification, GMP compliance, risk assessments, utility integration, facility modifications, and manufacturing readiness activities.

Services infusion pumps at hospitals and healthcare facilities across Puerto Rico. Installs, tests, operates, maintains, diagnoses, repairs, and modifies equipment; performs preventive maintenance; analyzes failures; implements corrective actions; maintains service records; supports quality and regulatory compliance; and trains customer personnel. Requires independent field work, customer scheduling, documentation, problem solving, vehicle ownership, local and international travel, and occasional overtime, weekend, and holiday availability.

Manage complex pharmaceutical and manufacturing projects from planning through completion, including budgets, schedules, resources, risks, governance, regulatory compliance, and cross-functional coordination. Lead initiatives involving new product introduction, technology transfer, process development, lifecycle management, commercialization, change control, and process validation. Prepare reports and presentations, resolve project issues, support senior management, and ensure project goals, quality standards, and timelines are achieved.

Develops and maintains quality standards for manufacturing processes, products, and equipment. Leads equipment, process, cleaning, and cleanroom validation activities; manages quality systems, change control, risk assessments, nonconformance investigations, and regulatory impact evaluations. Ensures audit-ready documentation and compliance with GMP, FDA, ISO 13485, and global requirements while supporting equipment purchases, relocations, requalification, and decommissioning.

Support pharmaceutical manufacturing Quality and Manufacturing operations through batch record review, GMP/GDP documentation compliance, SAP inventory management, electronic batch record workflows, quality event assessment, risk-based decision-making, and cross-functional communication. The role reviews data integrity and traceability, escalates compliance and operational risks, participates in DAI meetings, maintains shift handoffs, and supports timely, accurate decisions in a regulated manufacturing environment.

Supports pharmaceutical manufacturing and quality systems, including process validation, change controls, deviation investigations, CAPA, risk assessments, campaign readiness, Master Batch Records, manufacturing procedures, training, and process improvement. Provides floor troubleshooting, evaluates process and equipment changes, reviews performance data, supports functional testing, and serves as a recognized specialist in a manufacturing process area.

Develops, optimizes, and implements manufacturing processes, layouts, procedures, and documentation. Provides engineering support for equipment installation, qualification, validation, troubleshooting, investigations, and corrective actions. Uses statistical analysis and continuous improvement methods to enhance efficiency, quality, and productivity while ensuring regulatory compliance. Collaborates with cross-functional teams on manufacturing projects, timelines, and process improvements.

Supports GMP environmental monitoring and critical utilities trending, risk assessments, quality system activities, audits, inspections, change controls, deviations, and continuous improvement. Evaluates compliance with cGMP and FDA requirements, prepares and reviews technical documentation, and supports validation, commissioning, and qualification activities for manufacturing equipment and laboratory instrumentation.

Leads third-shift production activities, supervises and evaluates employees, trains new hires, ensures product quality, safety, compliance, housekeeping, and documentation, and performs basic process and equipment troubleshooting. The role also oversees shift closing procedures and ensures supervised personnel complete their responsibilities.

Leads engineering and equipment reliability initiatives in pharmaceutical manufacturing, including process optimization, troubleshooting, maintenance strategy development, equipment performance analysis, and capital projects. Manages CMMS work orders, preventive maintenance, spare parts, change control, deviations, CAPAs, and compliance activities. Serves as a manufacturing equipment SME, supervises engineers and technicians, and drives improvements in equipment availability, downtime reduction, system reliability, GMP compliance, and EHS performance.

Supports pharmaceutical manufacturing and quality systems, including process validation, change controls, deviation investigations, CAPA, risk assessments, campaign readiness, master batch records, procedures, training, and process improvements. Provides floor troubleshooting, technical writing, regulatory inspection support, and cross-functional collaboration. Requires bioprocessing knowledge, root cause analysis expertise, lean manufacturing familiarity, good documentation practices, and proficiency with manufacturing, quality, analytics, and collaboration platforms.

Manage complex pharmaceutical, biotech, medical device, and manufacturing projects from planning through commercialization and operational readiness. Responsibilities include overseeing scope, budgets, timelines, resources, governance, regulatory compliance, change control, risk management, cross-functional collaboration, reporting, and stakeholder communications. The role provides strategic leadership to project teams and supports New Product Introduction programs in matrixed environments.

Manage pharmaceutical and manufacturing New Product Introduction projects from planning through completion. Responsibilities include maintaining project plans and schedules, tracking budgets, coordinating resources, mitigating risks, addressing regulatory requirements, managing change control, aligning stakeholders, preparing reports and presentations, and supporting continuous process improvements across cross-functional teams.

Supports pharmaceutical manufacturing and quality systems, including change controls, deviation investigations, CAPAs, process validation, risk assessments, campaign readiness, procedure management, batch record revisions, technical testing, and process improvement. Provides floor troubleshooting, training support, regulatory inspection assistance, and cross-functional collaboration. Acts as a recognized specialist and process owner for manufacturing support systems.

Ensures supplier quality throughout acquisition and manufacturing, including supplier qualification, audits, inspection plans, measurement qualification, component acceptance, and resolution of supplier-related issues. The role supports regulated medical device, pharmaceutical, and biotechnology operations, collaborates with suppliers and cross-functional teams, and applies CAPA, root cause analysis, FMEA, control plans, and statistical sampling methods.

Designs and improves manufacturing processes, production layouts, equipment arrangements, operational sequences, and fabrication procedures. Evaluates machinery and tools, incorporates inspection and testing requirements, investigates performance deficiencies, and initiates corrective actions to maintain product quality. Develops processes compatible with statistical process control and supports manufacturing operations involving equipment installation, machining, material handling, CAD electrical design, PLC, HMI, and vision programming.

Recruit and screen candidates for multiple open positions, collaborate with hiring managers, coordinate drug testing and background checks, develop onboarding programs, conduct orientations, source talent through online networks, create job descriptions and interview materials, and manage interview and selection processes. The role also supports job fairs and recruiting events throughout Puerto Rico and is primarily on-site at customer locations.

Supports the design, programming, integration, and troubleshooting of automated manufacturing equipment and systems. Works with PLCs, vision systems, robotics, SCADA, HMI applications, CAD models, wiring schematics, and 3D designs. Contributes to R&D projects involving new technologies, develops utility programs, evaluates technical solutions and vendors, and ensures safety and quality compliance. May mentor junior colleagues or direct lower-level professionals.