Key Responsibilities and Required Skills for QA Officer

🎯 Role Definition

The QA Officer (Quality Assurance Officer) is responsible for maintaining and continuously improving the organization's Quality Management System (QMS) to ensure products and processes meet internal standards and external regulatory requirements. This role executes day-to-day quality control activities, drives investigations and CAPA, supports audits and inspections (internal, supplier, regulatory), and partners across manufacturing, R&D, supply chain, and commercial teams to reduce risk, improve compliance, and deliver consistent, high-quality products and services.

Key focus areas: quality system administration, document control, deviations and CAPA management, supplier quality and qualification, process and product release, audit readiness (ISO/GMP/HACCP/GLP/FDA), root cause analysis, metrics and continuous improvement.

📈 Career Progression

Typical Career Path

Entry Point From:

Quality Control Technician / QC Analyst
Production Operator with quality responsibilities
Laboratory Technician or Inspection Technician

Advancement To:

Senior QA Officer / QA Lead
Quality Assurance Manager / Quality Manager
Compliance Manager / Regulatory Affairs Specialist

Lateral Moves:

Process Improvement / Lean Engineer
Supplier Quality Engineer
Regulatory Affairs or Validation Specialist

Core Responsibilities

Primary Functions

Develop, implement and maintain the Quality Management System (QMS) procedures, work instructions, and forms in alignment with ISO 9001, GMP, GLP, or industry-specific standards to ensure consistent compliance and audit readiness across all operations.
Plan, conduct and document internal quality audits and process audits, create findings reports, and coordinate timely corrective and preventive actions (CAPA) to resolve nonconformances and reduce repeat issues.
Lead root cause analysis for deviations and non-conforming events using structured problem-solving methods (e.g., 5 Whys, Fishbone/Ishikawa, FMEA) and prepare investigation reports with robust corrective actions and verification steps.
Manage document control and change control processes including review, approval, distribution, training, and archiving of SOPs, batch records, quality manuals and controlled documents to ensure version control and traceability.
Perform batch release and product disposition activities based on review of test results, manufacturing records, and compliance checks, ensuring no release until quality acceptance criteria and release authority requirements are met.
Oversee inspection and in-process quality control activities on the production floor, including first article inspections, in-line sampling, visual inspections, and statistical process control (SPC) to reduce defects and rework.
Coordinate and execute supplier qualification and ongoing supplier performance management programs, including supplier audits, incoming material inspections, deviation handling, and supplier corrective actions.
Prepare, respond to and lead external regulatory inspections and customer audits by compiling evidence, conducting mock inspections, hosting auditor walkthroughs, and ensuring corrective actions are implemented and verified.
Monitor critical quality metrics and KPIs (e.g., OOS/OOT trends, CAPA closure rates, customer complaints, supplier performance, scrap rates) and deliver actionable insights and monthly quality reports to management.
Develop and deliver quality training programs for manufacturing, laboratory and support staff on GMP, SOPs, regulatory requirements, change control and quality culture to ensure competence and adherence across teams.
Maintain calibration, maintenance and qualification programs for laboratory equipment and production measuring instruments, ensuring all instruments are calibrated, validated and fit for intended use.
Support product and process validation activities, including developing validation protocols, conducting qualification runs (IQ/OQ/PQ), and documenting validation reports to substantiate product quality and process capability.
Manage customer complaints, returns and investigations by triaging cases, executing investigations, documenting root cause and corrective actions, communicating outcomes to stakeholders and tracking closure.
Implement risk-based quality strategies including risk assessments, FMEA, and control plans to proactively identify quality risks and prioritize mitigation activities as part of continuous improvement and compliance.
Review and approve incoming quality documentation, certificates of analysis (CoA), material specifications and release documents to ensure raw materials and components meet defined quality standards before use in production.
Collaborate with R&D and manufacturing teams on new product introductions (NPI) to ensure design transfer includes quality requirements, control plans, inspection criteria and validation activities.
Drive continuous improvement initiatives using Lean, Six Sigma or Kaizen methodologies to reduce variability, waste and cost while improving product quality and operational efficiency.
Maintain up-to-date knowledge of industry regulations and standards (e.g., FDA, MHRA, EU GMP, ISO 9001, HACCP) and advise stakeholders on regulatory impact, submission requirements and compliance strategies.
Oversee environmental, health and safety quality overlap where relevant (e.g., hygiene controls in food/pharma environments), ensuring that quality controls complement EHS initiatives and regulatory obligations.
Lead cross-functional quality review boards and change control committees, facilitating prioritization, technical review, and business impact assessment for proposed process or product changes.
Execute periodic management reviews and present quality performance, audit findings, CAPA status and strategic quality improvement plans to senior leadership to support decision-making.
Maintain traceability of production batches, materials and records for product recall readiness, and lead mock recall exercises to validate recall procedures and timeliness.
Manage quality-related IT systems (QMS software, LIMS, ERP modules) including user access, configuration of workflows, data integrity checks and liaising with IT for system upgrades and validations.
Ensure privacy and data integrity in all quality records, ensuring that electronic records and signatures comply with 21 CFR Part 11 and/or applicable regulatory guidance where relevant.

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.
Assist cross-functional teams with quality-related input for supplier onboarding and technical specifications.
Provide input to procurement and sourcing teams on quality agreements and acceptance criteria for new vendors.

Required Skills & Competencies

Hard Skills (Technical)

Quality Management Systems (QMS) administration and document control (ISO 9001, GMP, GLP, HACCP).
Auditing skills: internal audits, supplier audits, regulatory inspections and audit remediation.
CAPA and deviation management — investigation, root cause analysis and verification of effectiveness.
Statistical Process Control (SPC), basic statistics, and data analysis for quality metric tracking.
Process validation and qualification (IQ/OQ/PQ) and experience with validation documentation.
Knowledge of regulatory frameworks (FDA, EMA, MHRA, local regulatory bodies) and product-specific compliance.
Experience with laboratory quality systems, test methods, CoA review and instrument calibration.
Proficiency with QMS software, LIMS, ERP quality modules and Microsoft Excel (pivot tables, VLOOKUP).
Supplier quality management, vendor audits, incoming inspection and material release workflows.
Risk assessment tools: FMEA, HACCP, risk registers and mitigation planning.
Technical writing: SOPs, work instructions, investigation reports and audit findings.
Knowledge of Lean, Six Sigma or continuous improvement methodologies and tools.
Product recall planning, traceability systems and sample retention programs.
Electronic records and compliance (21 CFR Part 11 awareness where applicable).
Basic project management skills and ability to manage multiple concurrent quality projects.

Soft Skills

Strong attention to detail and commitment to quality and compliance.
Excellent written and verbal communication; ability to present technical findings to non-technical stakeholders.
Analytical mindset with problem solving and structured investigation capabilities.
Collaboration and cross-functional influence to drive process changes and corrective actions.
Time management, prioritization and ability to work under regulatory deadlines.
Integrity, ethical judgment and the ability to enforce quality standards impartially.
Adaptability to changing regulations, business priorities and production demands.
Coaching and training skills to elevate quality awareness across teams.

Education & Experience

Educational Background

Minimum Education:

Bachelor's degree (B.Sc. / B.Eng. / B.Tech) in a relevant field such as Life Sciences, Chemistry, Biochemistry, Engineering, Food Science, or a related technical discipline.

Preferred Education:

Bachelor’s plus relevant certifications (e.g., ISO Lead Auditor, Six Sigma Green/Black Belt, Certified Quality Professional) or a Master’s degree in a related discipline.

Relevant Fields of Study:

Quality Assurance / Quality Engineering
Pharmaceutical Sciences / Chemistry / Biochemistry
Mechanical / Chemical / Industrial Engineering
Food Science & Technology
Life Sciences / Biotechnology

Experience Requirements

Typical Experience Range:

2 to 6 years of progressive experience in quality assurance, quality control, or related technical roles. (Entry-level to mid-level QA Officer roles frequently require 2+ years; senior QA Officer roles typically require 4–6+ years.)

Preferred:

Demonstrated experience working within regulated industries (pharmaceuticals, medical devices, food, or chemical manufacturing) with direct responsibility for QMS activities, audits, CAPA, and product release.
Experience with ISO 9001, GMP/GLP, HACCP, FDA inspection readiness, supplier quality programs and quality software tools.