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Key Responsibilities and Required Skills for Quality Assurance Coordinator

💰 $ - $

Quality AssuranceOperationsComplianceManufacturing

🎯 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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