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

• Assist 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
  
  

Documentation & Record Management

• 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
• Ensure timely closure of quality events and proper documentation of dispositions
  
  

Calibration & Equipment Control

• Track calibration schedules and maintain calibration records
• Coordinate 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
• Ensure proper documentation and monitoring of controlled environments
• Assist in identifying and escalating environmental deviations
  
  

Change Control Support

• Assist in initiating and tracking change control requests
• Ensure required documentation and approvals are completed
• Support implementation and closure of change controls
  
  

Supplier Quality Support

• Assist in maintaining supplier qualification records
• Support incoming inspection and supplier performance monitoring
• Track supplier corrective actions and documentation
  
  

Software Validation & Data Integrity

• Support validation documentation for GxP software systems (e.g., IQ, OQ, PQ)
• Perform 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 with Quality Systems and documentation practices
  
  

Skills & Competencies

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

Working Conditions

• Involves 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
  
  

Working Conditions

Works under general supervision while learning new concepts quickly. Requires light physical activity performing non-strenuous daily activities.

• Must be able to lift up to 25 lbs.
• Must be able to sit or stand for long periods of time
• Must be able to climb up and down stairs
• Travel is required to support company initiatives
  
  

NOTE: This job description is not intended to be an exhaustive list of all possible duties, responsibilities and/or qualifications. Other duties, responsibilities and/or qualifications may be assigned to this position.