GMP-Driven Quality Operations Technician

Biopharma Careers; Irving (TX); On-site; USD 55,000 - 75,000; Full time

Job summary

Johnson & Johnson in Irving, Texas is seeking a Quality Operations Technician to perform technical QA inspections, support CAPA/NC initiatives, and ensure GMP and GDP compliance on the manufacturing floor. You will partner with QEs, collect quality data, conduct root cause analyses, and assist with MES, JDE and EtQ data searches to drive continuous improvement and product quality.

This role requires meticulous documentation, effective communication, and the ability to work independently or

Qualifications

• High School Education or GED is required.
• Minimum of two (2) years of experience is required.
• Professional certifications (CQAI, CQA or others) are desired.
• Green Belt Certification preferred.
• Project deployment experience is a plus.
• Previous experience in non-conformance investigations and root cause analysis desired.
• Attention to detail and robust documentation practices are required.
• Must be able to communicate training procedures, specifications, and procedures
• Must be able to work both independently and within cross-functional groups.
• Proficiency in ETQ, JDE, MES, MS Word and Excel is desired.
• Medical Device manufacturing experience is preferred.

Responsibilities

• Performs technical quality assurance inspections and issue resolution.
• Supports CAPA/NC initiatives on the manufacturing floors.
• Assists with data collection for quality metrics and quality systems.
• Conducts failure investigations and root cause analysis.
• Performs data searches and transactions within MES, JDE, and EtQ.
• Partners with QEs and business partners on NC processes and corrective actions.
• Influences the team with collaboration and teamwork on quality goals.
• Provides audit support and non-conformance disposition assistance.
• Reads and interprets drawings, QCICs, and test methods.
• Develops, prepares and reports technical information for nonconforming product disposition.
• Backups finished goods release trace activities.

Skills

Data Integrity

GMP

GDP

CAPA

Root Cause Analysis

Documentation

Cross-functional collab

Quality Assurance

Education

High School Diploma or GED

Tools

ETQ

JDE

MES

Minitab

MS Word

MS Excel

Job description

Johnson & Johnson in Irving, Texas is seeking a Quality Operations Technician to perform technical QA inspections, support CAPA/NC initiatives, and ensure GMP and GDP compliance on the manufacturing floor. You will partner with QEs, collect quality data, conduct root cause analyses, and assist with MES, JDE and EtQ data searches to drive continuous improvement and product quality.

This role requires meticulous documentation, effective communication, and the ability to work independently or