QA Specialist

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. 

Primary Responsibilities 

Quality Control & Testing (40%) 

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. 

Inspection & Testing 

• 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 

Quality Monitoring 

• 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 

Sampling & Statistical Methods 

• 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 

Compliance & Regulatory (30%) 

Ensures quality operations comply with applicable regulatory requirements, industry standards, and customer specifications while maintaining comprehensive documentation of compliance activities. 

Regulatory Compliance 

• 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 

Quality System Management 

• 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 

Non-Conformance Management 

• 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 

Documentation & Record Management (20%) 

Maintains accurate, complete, and readily retrievable quality records in compliance with regulatory requirements and company policies. 

Quality Documentation 

• 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 

Data Management & Reporting 

• 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 

Complaint Investigation 

• 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 

Process Improvement & Quality Engineering (10%) 

Drives continuous improvement initiatives to enhance product quality, reduce defects, and optimize quality processes. 

Continuous Improvement 

• 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 

Process Validation & Qualification 

• 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 

Training & Knowledge Sharing 

• 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 

Required Qualifications 

Education 

• 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 

Experience 

• 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