Quality Technician I

Job DetailsJob Location: Apex - Pittsfield - Pittsfield, MA 01201Position Type: Full TimeSalary Range: $32.00 - $35.00 HourlyJOB 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

QualificationsEDUCATION

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.