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quality assurance coordinator

title: Key Responsibilities and Required Skills for Quality Assurance Coordinator
salary: $ - $
categories: [Quality Assurance, Operations, Compliance, Manufacturing]
description: A comprehensive overview of the key responsibilities, required technical skills and professional background for the role of a Quality Assurance Coordinator.
Comprehensive, recruiter-style summary of the Quality Assurance Coordinator role optimized for SEO and LLMs. Includes detailed responsibilities, career progression, required technical and soft skills, education and experience expectations, and examples of cross-functional duties. Keywords: Quality Assurance Coordinator, QA Coordinator, quality control, GMP, ISO 9001, CAPA, SOP, audits, compliance, root cause analysis, supplier quality.

🎯 Role Definition

The Quality Assurance Coordinator is a hands-on QA professional responsible for coordinating and executing quality assurance activities across production, supplier management, documentation control, and continuous improvement programs. This role combines day-to-day operational oversight (inspections, nonconformance handling, CAPA execution) with process-focused activities (SOP maintenance, audit readiness, metrics reporting) to ensure product, process, and regulatory compliance. The ideal candidate will have experience with GMP/ISO environments, strong documentation discipline, and a proven ability to drive corrective actions and trend analysis across teams.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Quality Technician or Quality Inspector
  • Production/Manufacturing Associate with QA exposure
  • Laboratory Technician with quality or compliance duties

Advancement To:

  • Quality Assurance Supervisor / Lead
  • Quality Manager
  • Supplier Quality Engineer / Manager
  • Regulatory Affairs Specialist (for regulated industries)

Lateral Moves:

  • Process Improvement or Continuous Improvement Specialist
  • Compliance or Audit Coordinator
  • Document Control Specialist

Core Responsibilities

Primary Functions

  • Coordinate and execute incoming, in-process, and final inspections to verify product conformity to specifications, including generating inspection reports, disposition recommendations, and nonconformance documentation.
  • Own the nonconforming material (NCM) and deviation process: log incidents, assign containment actions, coordinate evaluations, and track dispositions to closure while communicating status to manufacturing and supply chain stakeholders.
  • Lead root cause investigations and drive CAPA activities end-to-end — draft corrective action plans, assign responsibilities, monitor implementation timelines, and verify effectiveness using data-driven metrics.
  • Maintain and revise Standard Operating Procedures (SOPs), work instructions, and quality forms to reflect current processes, ensuring controlled document revisions and training completion prior to release.
  • Plan, prepare for, and coordinate internal and external audits (supplier, customer, and regulatory); assemble audit evidence, facilitate auditor requests, and manage audit response and corrective action follow-up.
  • Perform supplier quality assessments and coordinate supplier corrective action requests (SCARs); monitor supplier performance KPIs, conduct supplier audits, and partner with procurement to resolve supply quality issues.
  • Generate, analyze, and present quality metrics and trend reports (reject rates, CAPA aging, audit findings, SPC charts) to leadership and cross-functional teams to support data-driven decision-making.
  • Support incoming supplier quality inspections, vendor qualification, and first-article inspections; ensure supplier documentation (Certificates of Conformance, test reports) meets specification requirements.
  • Facilitate product release and hold decisions by reviewing batch records, quality test results, and deviation reports; coordinate with QA/QC labs and production to ensure timely release while maintaining compliance.
  • Execute environmental monitoring and validation support activities as required (e.g., calibration records, equipment qualification, process validation documentation) to uphold GMP/regulated environment requirements.
  • Coordinate training programs for production and QA staff on quality policies, SOPs, inspection techniques, and corrective action outcomes; maintain training records and competency assessments.
  • Support the change control process: evaluate proposed changes for quality/regulatory impact, facilitate review and approval cycles, and ensure changes are communicated and implemented correctly.
  • Manage document control and records retention for quality systems — ensure accurate filing of quality records, batch records, test data, and audit documentation consistent with company policies and regulatory requirements.
  • Participate in cross-functional continuous improvement projects (Lean, Six Sigma, process mapping) to reduce defects, streamline inspection processes, and improve overall operational quality.
  • Execute sample collection and coordinate laboratory testing workflow between production and QC labs; ensure chain-of-custody, labeling, and sample documentation are complete and compliant.
  • Investigate customer complaints and returns: perform root cause analysis, coordinate corrective actions with production and suppliers, and prepare response documentation for customers and regulatory bodies when needed.
  • Support product change notifications and customer-facing quality communications; draft technical reports and supporting materials for customer inquiries or regulatory submissions.
  • Monitor regulatory and industry guidance updates (ISO standards, GMP, FDA/MHRA/EMA guidance) and support the implementation of required quality system changes.
  • Coordinate calibration and maintenance schedules for critical quality and inspection equipment, ensuring calibration certificates are current and equipment is qualified for use.
  • Maintain a controlled CMMS or quality database (e.g., LIMS, QMS, SAP QM) by entering nonconformances, tracking CAPAs, updating SOP versions, and generating quality performance dashboards.

Secondary Functions

  • Support ad-hoc investigations into production variances and provide technical input for cross-functional troubleshooting sessions.
  • Assist with risk assessments (FMEA, risk registers) for manufacturing processes and new product introductions to reduce quality risk at scale.
  • Contribute to continuous improvement initiatives by collecting operational data, proposing procedural improvements, and piloting corrective actions on the shop floor.
  • Act as the QA representative in daily production meetings to escalate quality concerns, provide inspection status, and recommend containment strategies.
  • Coordinate sample retention and archiving processes to ensure traceability for investigations and regulatory inspections.
  • Assist in the preparation and maintenance of quality system documentation for ISO 9001 or other relevant certifications.
  • Support release testing coordination and ensure test protocols and acceptance criteria are met prior to product shipment.
  • Provide backup support for the quality lab by assisting with basic analytical testing, record review, or data entry as required.
  • Participate in supplier onboarding activities, ensuring new vendors meet defined quality and documentation requirements before approval.
  • Support continuous data collection and ad-hoc reporting requests for management or external stakeholders related to quality performance.

Required Skills & Competencies

Hard Skills (Technical)

  • Quality Management Systems (QMS) administration and document control (ISO 9001 experience strongly preferred).
  • Knowledge of Good Manufacturing Practices (GMP) and regulatory compliance for regulated industries (pharmaceuticals, medical devices, food, etc.).
  • CAPA administration and root cause analysis techniques (5 Whys, Ishikawa/fishbone, Pareto analysis).
  • Audit preparation and execution skills for internal, supplier, and external regulatory audits.
  • Experience with statistical process control (SPC), trend analysis, and quality metrics reporting (e.g., OEE, defect rates).
  • Proficiency with quality-related software: LIMS, QMS platforms, SAP QM, MasterControl, TrackWise, or similar.
  • Supplier quality management including SCAR issuance, supplier performance metrics, and supplier audits.
  • Document authoring and revision control for SOPs, batch records, and validation protocols.
  • Familiarity with testing procedures, sample handling, chain-of-custody, and laboratory coordination.
  • Change control and risk assessment methodologies (FMEA, risk registers) and implementation.
  • Calibration program oversight and equipment qualification (IQ/OQ/PQ basics).
  • Basic data analysis skills using Excel (pivot tables, v-lookups), and experience creating quality dashboards.

Soft Skills

  • Strong attention to detail with a bias for accuracy in documentation, inspections, and data reporting.
  • Excellent written and verbal communication skills for cross-functional coordination, audit responses, and supplier interactions.
  • Problem-solving mindset with the ability to lead investigations and deliver actionable corrective actions under time pressure.
  • Project management and organizational skills to manage multiple CAPAs, audits, and release activities concurrently.
  • Ability to influence and build relationships across production, engineering, supply chain, and external vendors.
  • Customer-focused orientation for handling complaints, returns, and external quality inquiries diplomatically.
  • Adaptability and resilience in fast-paced manufacturing or regulated environments.
  • Collaborative team player who can facilitate meetings, training sessions, and cross-functional workshops.
  • Analytical thinking with the ability to interpret quality data and present insights to technical and non-technical audiences.
  • Integrity and ethical judgment when enforcing quality policies and handling sensitive compliance issues.

Education & Experience

Educational Background

Minimum Education:

  • Associate degree in Quality Assurance, Manufacturing Technology, Biological Sciences, Engineering, or related technical field.

Preferred Education:

  • Bachelor’s degree in Quality Assurance, Industrial Engineering, Biotechnology, Chemistry, Life Sciences, or Manufacturing Engineering.

Relevant Fields of Study:

  • Quality Assurance / Quality Engineering
  • Industrial or Manufacturing Engineering
  • Biological Sciences, Chemistry, or related laboratory sciences
  • Regulatory Affairs / Compliance

Experience Requirements

Typical Experience Range: 2–5 years in quality, manufacturing, or laboratory environments; minimum 1–2 years for entry-level coordinator roles.

Preferred:

  • 3+ years of progressive QA experience in regulated industries (medical device, pharmaceutical, food & beverage, or contract manufacturing).
  • Demonstrated experience in audits, CAPA management, SOP control, and supplier quality functions.
  • Certifications a plus: ASQ Certified Quality Improvement Associate (CQIA), Certified Quality Technician (CQT), ISO 9001 Lead Auditor, or similar.
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