QA Specialist

JLL•Gurabo, PR

3d•Onsite

About The Position

JLL empowers you to shape a brighter way. Our people at JLL are shaping the future of real estate for a better world by combining world class services, advisory and technology for our clients. We are committed to hiring the best, most talented people and empowering them to thrive, grow meaningful careers and to find a place where they belong. Whether you’ve got deep experience in commercial real estate, skilled trades or technology, or you’re looking to apply your relevant experience to a new industry, join our team as we help shape a brighter way forward. Position Summary The QA Specialist is responsible for ensuring product quality, process compliance, and continuous improvement within manufacturing or service delivery operations. This role combines quality control activities (40%), compliance monitoring (30%), documentation management (20%), and process improvement initiatives (10%) to maintain the highest standards of quality and regulatory adherence. The ideal candidate will demonstrate strong analytical skills, meticulous attention to detail, and the ability to collaborate effectively across multiple departments while maintaining rigorous quality standards.

Requirements

Bachelor's degree in Quality Engineering , Industrial Engineering, Chemistry, Biology, or related technical field
Equivalent combination of education and directly related experience may be considered
Minimum 3-5 years of experience in quality assurance or quality control roles in manufacturing, pharmaceutical, medical device, or regulated industries
Proven track record of conducting inspections, testing, and documentation in compliance with regulatory requirements
Experience with quality management systems (ISO 9001, ISO 13485, FDA 21 CFR Part 820, or similar)
Demonstrated experience investigating non-conformances and implementing corrective actions
Experience with statistical process control and data analysis techniques preferred

Nice To Haves

Master's degree in related field
ASQ Certified Quality Engineer (CQE) or Certified Reliability Engineer (CRE)
Experience in pharmaceutical, biotechnology, or medical device industries
Knowledge of validation protocols and qualification processes
Training in Lean Manufacturing, Kaizen, or Value Stream Mapping methodologies
Experience with enterprise resource planning (ERP) systems (SAP, Oracle, etc.)
Bilingual capabilities (English plus Spanish or other relevant language)
Experience with automated inspection systems and vision technology

Responsibilities

Serves as the primary quality resource for assigned production lines or service areas, implementing and maintaining comprehensive quality control programs that ensure products and services meet established specifications and customer requirements.
Conducts in-process inspections and final product inspections according to established sampling plans and quality standards
Performs physical, chemical, and functional testing using calibrated equipment and standardized test methods
Reviews and interprets test results, comparing against specifications to determine accept/reject decisions
Documents inspection findings and test data accurately in quality management systems
Identifies non-conforming materials or products and initiates appropriate containment and disposition actions
Operates and maintains inspection and testing equipment including micrometers, calipers, spectrophotometers, and specialized testing apparatus
Verifies proper calibration status of measurement equipment before use
Monitors production processes to ensure adherence to quality standards and work instructions
Conducts first article inspections for new production runs or process changes
Performs receiving inspections of raw materials, components, and supplies from vendors
Tracks and trends quality metrics including defect rates, first pass yield, and customer complaints
Identifies quality issues in real-time and escalates concerns to production and management teams
Participates in production line trials and validation activities for new products or processes
Conducts periodic audits of workstations to verify compliance with quality procedures
Implements statistical sampling plans (AQL, ANSI/ASQ Z1.4, etc.) appropriate to risk level
Collects representative samples following established protocols
Applies statistical process control (SPC) techniques to monitor process stability
Creates and maintains control charts to identify trends and out-of-control conditions
Calculates process capability indices (Cp, Cpk ) to assess process performance
Uses statistical software to analyze quality data and generate reports
Ensures quality operations comply with applicable regulatory requirements, industry standards, and customer specifications while maintaining comprehensive documentation of compliance activities.
Maintains compliance with FDA regulations (21 CFR), ISO standards (ISO 9001, ISO 13485), and other applicable quality system requirements
Supports regulatory inspections and audits by FDA, notified bodies, and customer auditors
Prepares inspection readiness materials and coordinates inspection logistics
Responds to inspector observations and implements corrective actions
Monitors changes in applicable regulations and updates procedures accordingly
Maintains current knowledge of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP)
Ensures compliance with customer-specific quality requirements and specifications
Implements and maintains quality management system (QMS) procedures and work instructions
Conducts internal audits of quality processes, production operations, and documentation practices
Verifies effectiveness of corrective and preventive actions (CAPA) implementation
Maintains audit schedules and tracks audit findings through closure
Supports document control processes including review, approval, and change management
Ensures proper training and competency verification for personnel performing quality-related tasks
Participates in management review meetings and quality council activities
Investigates product non-conformances and process deviations
Documents non-conformances in quality management systems with detailed descriptions and photographic evidence
Coordinates disposition decisions for non-conforming materials (use-as-is, rework, scrap, return to vendor)
Initiates and tracks corrective action requests through completion
Analyzes non-conformance trends to identify systemic issues
Manages material review board (MRB) processes and documentation
Communicates quality issues to affected departments and stakeholders
Maintains accurate , complete, and readily retrievable quality records in compliance with regulatory requirements and company policies.
Creates, reviews, and approves quality procedures, work instructions, and specifications
Maintains batch records, inspection reports, test certificates, and quality release documentation
Ensures completeness and accuracy of all quality records before final approval
Manages document change control processes including revision history tracking
Maintains master document lists and ensures obsolete documents are removed from use
Organizes and archives quality records according to retention schedules
Prepares certificates of analysis (CoA) and certificates of conformance (CoC) for customers
Enters inspection and test data into quality management systems and databases
Generates daily, weekly, and monthly quality performance reports
Creates dashboards and visualizations to communicate quality metrics to stakeholders
Analyzes historical quality data to identify trends and improvement opportunities
Maintains traceability records linking raw materials to finished products
Prepares quality reports for customer reviews and management meetings
Supports product release processes by verifying all quality documentation is complete and acceptable
Receives and logs customer complaints in complaint management systems
Conducts investigations to determine root cause of quality issues
Coordinates with cross-functional teams (production, engineering, supply chain) during investigations
Prepares formal investigation reports with findings and corrective actions
Communicates investigation results to customers within required timeframes
Tracks complaint trends and initiates preventive actions to address recurring issues
Maintains complaint files and supports regulatory reporting of adverse events when applicable
Drives continuous improvement initiatives to enhance product quality, reduce defects, and optimize quality processes.
Participates in Lean, Six Sigma, and continuous improvement projects
Identifies opportunities to improve quality processes, reduce inspection time, and eliminate waste
Facilitates root cause analysis activities using 5-Why, Fishbone, and other problem-solving methodologies
Develops and implements preventive measures to address potential quality risks
Supports value stream mapping and process optimization initiatives
Collects voice of customer ( VoC ) data to inform quality improvement priorities
Tracks and communicates cost of quality metrics
Supports installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities
Participates in validation protocol development and execution
Reviews validation data and prepares validation summary reports
Assists in equipment qualification and requalification activities
Supports process capability studies for new and existing processes
Maintains validation documentation and schedules periodic revalidation activities
Delivers quality training to production personnel, new hires, and contractors
Creates training materials including presentations, videos, and visual aids
Conducts competency assessments and maintains training records
Mentors junior quality personnel and production operators on quality standards
Shares best practices and lessons learned across the organization
Promotes quality awareness and a culture of quality excellence