Key Responsibilities and Required Skills for Quality Assurance Administrator

🎯 Role Definition

The Quality Assurance Administrator serves as the operational backbone of the quality organization, administering the Quality Management System (QMS), ensuring documentation and records integrity, coordinating internal and external audits, tracking non-conformances and CAPA activities, and producing timely quality metrics and reports. This role supports cross-functional teams (operations, manufacturing, engineering, regulatory, supply chain) to ensure products, services, and processes meet company quality standards and applicable regulatory requirements. Ideal candidates will be detail-oriented, process-driven, and experienced in document control, audit coordination, root-cause investigation support, and continuous improvement initiatives.

📈 Career Progression

Typical Career Path

Entry Point From:

Quality Technician / QC Inspector
Manufacturing Associate with quality responsibilities
Administrative Specialist supporting QA/QC teams

Advancement To:

Quality Specialist / Quality Engineer
Quality Supervisor / Quality Coordinator
Quality Systems Manager or Compliance Manager

Lateral Moves:

Regulatory Affairs Associate
Supplier Quality Coordinator
Continuous Improvement / Lean Coordinator

Core Responsibilities

Primary Functions

Maintain and administer the Quality Management System (QMS), including creation, revision, distribution and archiving of Standard Operating Procedures (SOPs), work instructions, forms and controlled documents to ensure version control and compliance with ISO 9001, ISO 13485, FDA 21 CFR Part 820, or other applicable standards.
Serve as document control owner: issue and retire controlled documents, implement document numbering conventions, manage electronic document management systems (EDMS), and train stakeholders on document change procedures.
Coordinate, schedule and support internal audits, management reviews, and supplier audits; prepare audit plans, checklists and evidence packages; record and track audit findings to closure.
Log, route, and manage non-conformances (NCs) and product / process deviations in the CAPA / issue tracking system; ensure timely investigation, root cause analysis (RCA), corrective and preventive action plans, and verification of effectiveness.
Prepare and maintain quality records and regulatory documentation required for inspections and audits, including audit reports, CAPA files, test records, training matrices, and calibration logs.
Support supplier quality activities: maintain approved supplier lists, document supplier performance metrics, prepare supplier non-conformance reports (NCRs), and coordinate supplier corrective actions and requalification activities.
Facilitate change control processes: intake change requests, evaluate documentation completeness, coordinate cross-functional impact assessments, and maintain change control logs and approvals.
Assist with complaint handling and product return investigations: log complaints, coordinate triage, collect evidence, support root-cause investigations, and track remediation toward closure while ensuring regulatory reporting timelines are met.
Administer and maintain calibration and preventive maintenance schedules for quality measurement equipment; coordinate external calibration vendors and maintain calibration certificates and traceability.
Develop, collect, and analyze quality metrics and KPIs (e.g., PPM, scrap, returns, on-time corrective action closure, audit scores); prepare weekly/monthly dashboards and executive summaries to communicate quality performance.
Support validation and verification activities for new and existing processes and equipment, including IQ/OQ/PQ document coordination, test plan preparation, and test execution tracking.
Assist in the creation and maintenance of product specifications, inspection plans, sampling procedures and acceptance criteria to support production release decisions and incoming inspection.
Manage sample retention programs, labeling and quarantine practices, ensuring traceability and integrity of retained samples for investigations and regulatory requirements.
Coordinate quality-related training programs: maintain the training matrix, schedule required training, track completion and competency records, and escalate overdue training to department leads.
Prepare and distribute quality communications such as non-conformance notices, CAPA summaries, audit findings, and updates to stakeholders to ensure visibility and prompt action.
Support cross-functional investigations by compiling data, preparing timelines, extracting production and test records, facilitating interviews and documenting investigation outcomes.
Oversee the product release process from a quality perspective: review batch records and test results for completeness, raise hold/release actions where required, and document release approvals.
Participate in risk management activities: assist with FMEA updates, risk assessments, mitigation tracking and incorporation of risk controls into procedures and work instructions.
Maintain environmental monitoring records and coordinate sampling or inspection activities as required for regulated environments (cleanrooms, controlled areas).
Act as a point of contact for external auditors and regulatory inspectors: prepare requested documentation, coordinate walkthroughs, and support responses to audit observations and action plans.
Implement continuous improvement projects within the QA administrative domain to reduce administrative cycle times, improve data integrity, and enhance audit readiness.
Ensure proper disposal and archival of quality records in accordance with retention policies and regulatory requirements; manage electronic and physical record retention and retrieval processes.
Support electronic quality systems (QMS software, LIMS, MES) including user administration, configuration updates, report creation, and user training where required.

Secondary Functions

Provide ad-hoc quality data requests and exploratory data analysis to support investigations, management reviews, and continuous improvement initiatives.
Contribute to the organization’s quality strategy and roadmap by identifying gaps in administrative processes and recommending system/process enhancements.
Collaborate with cross-functional business units (production, engineering, supply chain, regulatory) to translate operational quality needs into QMS requirements and process improvements.
Participate in sprint planning and agile ceremonies when the quality or LIMS/QMS team is organized in an agile way; support backlog grooming and task estimation for quality system enhancements.
Support special projects such as new product introductions, plant expansions, or ERP/LIMS implementations by providing quality system, documentation, and compliance input.
Assist with preparation of management review materials, CAPA trend analysis, and continuous improvement prioritization based on data-driven insights.

Required Skills & Competencies

Hard Skills (Technical)

Quality Management Systems (QMS) administration and document control (EDMS experience e.g., MasterControl, Veeva Vault, Q-Pulse, Greenlight Guru).
CAPA and NCR management, including root cause analysis techniques (5 Whys, Fishbone/Ishikawa, 8D) and verification of corrective actions.
Internal and supplier audit coordination, audit scheduling, checklist development, and audit report preparation.
Knowledge of regulatory standards and frameworks: ISO 9001, ISO 13485, FDA 21 CFR Part 820, GMP, GxP, OSHA, as applicable to industry.
Experience with quality and manufacturing systems: LIMS, MES, ERP (SAP/Oracle/JD Edwards), and QMS workflow configuration.
Data analysis and reporting skills: Excel (pivot tables, VLOOKUP), Power BI/Tableau for KPI dashboards, and ability to interpret quality metrics.
Document authoring and control: creating SOPs, WI, forms, and managing revision control processes.
Change control, product release processes, batch record review, and configuration management.
Calibration and equipment control administration, including certificate management and scheduling.
Complaint handling, product return investigation, and sample retention program administration.
Validation support (IQ/OQ/PQ) and familiarity with validation lifecycle documentation.
Supplier quality coordination and basic supplier performance metrics tracking.

Soft Skills

Strong attention to detail and high personal accountability for quality of documentation and data integrity.
Excellent written and verbal communication skills for clear audit narratives, CAPA reports, and cross-functional updates.
Organizational and time-management skills to manage competing priorities, audit schedules, and regulatory timelines.
Analytical and problem-solving mindset with the ability to synthesize data and present actionable insights.
Collaborative team player who can work effectively with manufacturing, engineering, regulatory, and supply chain partners.
Customer-focused orientation to ensure both internal and external customer requirements are met.
Adaptable and resilient — comfortable working in regulated, fast-paced or changing environments.
Continuous improvement mindset with experience facilitating small process improvement projects.

Education & Experience

Educational Background

Minimum Education:

Associate degree or diploma in Quality Assurance, Engineering Technology, Life Sciences, Manufacturing Technology, or related technical field.

Preferred Education:

Bachelor’s degree in Quality Engineering, Industrial Engineering, Mechanical/Manufacturing Engineering, Biology/Chemistry (for regulated industries) or related discipline.
Certifications such as CQE, CQA, Six Sigma Yellow/Green Belt, ASQ, or ISO Lead Auditor preferred.

Relevant Fields of Study:

Quality Assurance / Quality Control
Engineering (Industrial, Mechanical, Chemical, Biomedical)
Life Sciences (Biology, Chemistry) for pharmaceutical/medical device roles
Manufacturing Technology / Operations Management

Experience Requirements

Typical Experience Range: 2–6 years in quality administration, quality control, document control or related roles within manufacturing, regulated industries, or technical services.

Preferred:

3+ years administering a QMS in a regulated environment (medical device, pharmaceuticals, food & beverage, aerospace, automotive).
Demonstrated experience with electronic QMS platforms, CAPA/NCR systems, audit coordination, and preparing documentation for regulatory inspections.
Proven track record of driving administrative process improvements, improving data integrity, and supporting cross-functional investigations and corrective actions.