Key Responsibilities and Required Skills for Quality Assurance Representative

🎯 Role Definition

The Quality Assurance Representative (QA Representative) is responsible for monitoring, testing, documenting, and improving product and process quality across manufacturing, distribution, or service environments. This role enforces regulatory and company standards (e.g., GMP, ISO 9001, FDA), performs inspections and audits, drives corrective and preventive actions (CAPA), maintains quality records and standard operating procedures (SOPs), and collaborates cross-functionally to reduce defects, ensure product release, and improve customer satisfaction. The ideal candidate combines technical inspection and testing skills with strong documentation, communication, and continuous-improvement instincts.

📈 Career Progression

Typical Career Path

Entry Point From:

Quality Control Technician / Inspector
Production Operator or Manufacturing Technician
Customer Service Representative with quality remit

Advancement To:

Senior Quality Assurance Representative
Quality Supervisor / Lead
Quality Manager / Quality Systems Manager
Regulatory Affairs Specialist or Compliance Manager

Lateral Moves:

Process Improvement / Continuous Improvement Specialist
Supplier Quality Engineer
Validation / Calibration Technician

Core Responsibilities

Primary Functions

Execute incoming materials inspection and testing according to documented sampling plans and acceptance criteria, documenting results in the quality management system and communicating non-conforming material to purchasing and suppliers.
Perform in-process inspections and tests across manufacturing stages to verify process controls, dimensional tolerances, and product specifications; stop production and escalate when deviations compromise product quality or safety.
Conduct final product release verification, ensuring product traceability, batch records completeness, labeling accuracy, and compliance with release criteria prior to shipment.
Lead, plan, and perform internal quality audits (process, product, and system audits) using established checklists; prepare audit reports, document findings, and follow-up on corrective actions until closure.
Investigate customer complaints and product failures, perform root-cause analysis (RCA), implement and verify corrective and preventive actions (CAPA), and report trends to management to reduce recurrence.
Maintain, review, and update standard operating procedures (SOPs), work instructions, and quality forms to reflect current processes, regulatory expectations, and continuous improvement outcomes.
Monitor and report quality metrics (e.g., defect rates, scrap, yield, PPM, first-pass yield) on a recurring basis and present findings to cross-functional teams to drive data-led improvement initiatives.
Participate in new product introductions and process change control reviews to ensure design-for-quality, validate new production methods, and approve manufacturing readiness.
Perform supplier quality assessments, approve supplier inspection reports, and collaborate with procurement and suppliers to resolve non-conformances and improve incoming quality.
Administer environmental and stability monitoring programs (where applicable), execute sampling protocols, and maintain environmental logs to conform with regulatory and company requirements.
Operate and maintain laboratory and inspection equipment, execute calibration checks, and coordinate with calibration teams to keep measuring instruments within certified tolerances.
Execute statistical process control (SPC) activities, collect and analyze control chart data, and recommend process adjustments to maintain stability and capability.
Manage non-conforming material disposition, including quarantine, rework, return to vendor, or scrap decisions with documented rationale and cross-functional approval.
Support process validations and qualification protocols (IQ/OQ/PQ) by executing test plans, collecting validation data, and verifying acceptance criteria are met prior to full production release.
Participate in cross-functional CAPA teams and change control boards to evaluate quality impact, risk, and mitigation strategies for manufacturing, product, and system changes.
Maintain complete and accurate quality documentation, batch records, certificates of analysis (COAs), and regulatory files to support audits and inspections by customers and regulators.
Train production and operations staff on quality procedures, inspection techniques, and root-cause prevention to embed quality ownership on the shop floor.
Use quality management systems (QMS), Laboratory Information Management Systems (LIMS), or ERP modules to log inspections, track CAPAs, and manage documentation in accordance with document control procedures.
Support product complaint handling including triage, technical evaluation, corrective action recommendation, and timely customer communication in collaboration with Customer Service and Regulatory Affairs.
Perform risk assessments (FMEA, risk matrix) and participate in continuous improvement activities, Kaizen events, or Lean Six Sigma projects to reduce variation and improve process capability.
Review and approve labeling, packaging, and shipping quality checks to ensure product integrity and regulatory compliance during transport and storage.
Maintain up-to-date knowledge of relevant regulations (FDA, cGMP, ISO 9001, ISO 13485, local regulatory requirements) and ensure ongoing conformance across operations.
Coordinate and support external audits and inspections by customers, certification bodies, and regulatory agencies; prepare documentation, lead site tours, and implement audit corrective actions.

Secondary Functions

Support ad-hoc data requests and exploratory data analysis.
Contribute to the organization's data strategy and roadmap.
Collaborate with business units to translate data needs into engineering requirements.
Participate in sprint planning and agile ceremonies within the data engineering team.
Provide backup support for quality documentation control and release processes during peak periods or staff absence.
Assist in supplier onboarding activities by providing quality-related requirements, inspection criteria, and training materials.
Support continuous improvement workshops by supplying quality data and failure analysis to identify root causes and improvement ideas.

Required Skills & Competencies

Hard Skills (Technical)

Quality inspection and testing methodologies (visual, dimensional, functional testing).
Regulatory knowledge: cGMP, FDA regulations, ISO 9001 (or industry-specific standards such as ISO 13485, IATF 16949, HACCP).
Document control and quality management system (QMS) usage (e.g., MasterControl, TrackWise, Greenlight).
Root cause analysis techniques: 5 Whys, Fishbone (Ishikawa), FMEA.
CAPA management — initiation, investigation, implementation, verification, and closure.
Statistical tools and SPC (control charts, process capability analysis).
Experience with laboratory practices and LIMS or test-data systems.
Proficiency with MS Excel (pivot tables, VLOOKUP/XLOOKUP, basic macros) and data reporting.
Experience with ERP systems (e.g., SAP, Oracle) for lot tracking, inventory, and quality records.
Knowledge of sampling plans, AQL, and acceptance criteria for incoming and final inspections.
Product/process validation and qualification (IQ/OQ/PQ) experience.
Calibration fundamentals and coordination of calibration schedules and records.

Soft Skills

Exceptional attention to detail and commitment to accuracy in documentation and inspections.
Strong written and verbal communication skills for clear cross-functional reporting and audit responses.
Analytical and problem-solving mindset with the ability to interpret data and recommend corrective actions.
Time management and prioritization ability to handle multiple investigations and releases under deadlines.
Collaboration and stakeholder management across operations, engineering, procurement, and customer service.
Integrity, ethical judgment, and an evidence-based approach to decision-making.
Adaptability to changing regulatory requirements and fast-paced production environments.
Coaching and training skills to educate production staff on quality expectations and SOPs.
Customer-focused orientation to resolve complaints and support product improvements.
Initiative and continuous improvement mindset, comfortable leading or participating in Kaizen or Lean events.

Education & Experience

Educational Background

Minimum Education:

High school diploma or equivalent; vocational/technical certification in quality, inspection, or related field preferred.

Preferred Education:

Associate or Bachelor's degree in Quality Assurance, Engineering, Biology, Chemistry, Manufacturing, or a related technical field.
Certifications such as ASQ Certified Quality Inspector (CQI), Quality Auditor (CQA), Six Sigma Yellow/Green Belt, or industry-specific compliance training are advantageous.

Relevant Fields of Study:

Quality Assurance / Quality Engineering
Manufacturing or Industrial Engineering
Biology, Chemistry or Life Sciences (for regulated industries)
Mechanical or Electrical Engineering (for product/assembly environments)
Supply Chain / Operations Management

Experience Requirements

Typical Experience Range: 1–5 years of quality or inspection experience in manufacturing, lab, regulated environment, or customer-facing quality roles.

Preferred:

2–4+ years performing inspections, audits, CAPA, and documentation in a regulated or high-volume production environment.
Demonstrated experience with QMS software, audit execution, supplier quality interactions, and cross-functional problem solving.