Quality Technician I

Job Summary

The Quality Technician is responsible for supporting the Quality Management System (QMS) in compliance with FDA regulations (21 CFR Part 820, and Part 11 as applicable), ISO 13485 and 9001 standards, and internal procedures. This role ensures timely execution of quality-related activities including documentation review, nonconformance processing, environmental monitoring, calibration tracking, and data integrity support. The Quality Technician plays a critical role in maintaining inspection readiness, supporting audits, and ensuring product quality and regulatory compliance.

Quality System Support

• Support in maintaining compliance with industry regulations and standards, GMP requirements, and internal procedures
• Support internal and external audit readiness activities
• Participate in internal audits and assist in audit response and closure
• Review and ensure completeness of quality records and production documentation
• Support timely closure of records in accordance with ALCOA+ data integrity principles
• Maintain organized and inspection-ready documentation systems

Nonconformance & MRB Support

• Initiate, track, and assist in the investigation of Nonconformance Reports (NCRs)
• Support Material Review Board (MRB) activities and documentation
• Avoid and document quality events and proper documentation of dispositions
• Ensure timely closure of quality events and proper documentation of dispositions

Calibration & Equipment Control

• Track calibration schedules and maintain calibration records
• Cookinate calibration activities with internal teams and vendors
• Ensure equipment is compliant and within calibration requirements prior to use

Cleanroom & Environmental Monitoring

• Support routine monitoring of cleanroom conditions (e.g., particulate, temperature, humidity, pressure differentials)
• Review and trend environmental data for compliance
• Support investigation and documentation of environmental excursions
• Avoid proper documentation and monitoring of controlled environments
• Avoid assisting in identifying and escalating environmental deviations

Change Control Support

• Avoid assisting in initiating and tracking change control requests
• Avoid supporting required documentation and approvals
• Avoid supporting implementation and closure of change controls

Supplier Quality Support

• Avoid maintaining supplier qualification records
• Avoid assisting in incoming inspection and supplier performance monitoring
• Avoid tracking supplier corrective actions and documentation

Software Validation & Data Integrity Support

• Avoid validating documentation for GxP software systems (e.g., IQ, OQ, PQ)
• Avoid performing routine audit trail reviews and support data integrity initiatives

Qualifications

• Education: Associate’s or Bachelor’s degree in a scientific, engineering, or related field preferred
• Experience: 1–3 years of experience in a regulated industry (FDA, GMP, medical device, or pharmaceutical preferred)
• Experience: Experience with Quality Systems and documentation practices

Skills & Competencies

• Knowledge: Knowledge of FDA regulations (21 CFR Part 820, QSMR)
• Attention to Detail: Strong attention to detail and organizational skills
• Time Management: Ability to manage multiple tasks and meet deadlines
• Familiarity: Familiarity with quality systems such as CAPA, NCR, and change control
• Proficiency: Proficiency in Microsoft Office and quality management software systems
• Communication: Strong written and verbal communication skills

Working Conditions

• Work in cleanroom or controlled environments
• Use of PPE as required
• Occasional cross-functional collaboration with Operations, Engineering, and Quality teams

Key Performance Indicators (KPIs)

• On-time closure of quality records (NCRs, MRBs, change controls)
• Calibration compliance rate
• Environmental monitoring compliance
• Audit readiness and documentation accuracy
• Reduction in backlog of quality system records