Quality Assurance Technician — GMP/Data Integrity

Biopharma Careers; Irving (TX); On-site; USD 52,000 - 90,000; Full time

Job summary

Johnson & Johnson in Irving, TX is seeking a Quality Operations Technician to conduct QA inspections, support CAPAs, and help ensure GMP/compliance on the production floor.

You will collect quality metrics, perform investigations, and collaborate with QEs and other teams to resolve nonconformances while maintaining thorough documentation.

Experience with ETQ, JDE or MES is a plus; high attention to detail and ability to work independently are required.

Qualifications

• High school education or GED required.
• Minimum of two years of experience required.
• Professional certifications (CQAI, CQA or others) desired.
• Green Belt Certification preferred.
• Project deployment experience is a plus.
• Experience in non-conformance investigations and root cause analysis desired.
• Attention to detail and robust documentation practices required.
• Ability to communicate training procedures, specifications, and procedures.
• Ability to work independently and in cross-functional groups.
• Proficiency in ETQ, JDE, MES, MS Word and Excel desired.
• Minitab experience for projects and problem solving.
• Medical Device manufacturing experience preferred.

Responsibilities

• Supports Quality Operation functions including CAPA/NC initiatives, on-floor presence, and GDP/data integrity.
• Assists with data collection for quality metrics and quality improvement initiatives.
• Conducts failure investigations and root cause analysis.
• Performs data searches in MES, JDE, and EtQ.
• Collaborates with QEs and partners on NC processes and corrective actions.
• Models collaboration and teamwork on the floor.
• Provides audit support (internal and external).
• Reads/interprets drawings, QCICs and test methods, executes tasks.
• Prepares and reports technical information to disposition nonconforming product.
• Supports periodic reviews of Quality Operations.
• Backups finished good release trace activities.
• Supports quality improvement projects.
• Adheres to GMP, data integrity, and GDP standards.

Skills

Agility

Compliance management

Curious mindset

Customer centricity

Detail oriented

Document management

Factory Acceptance Test

Persistence and tenacity

Process oriented

Professional ethics

Quality control

Quality control testing

Quality standards

Quality systems documentation

Regulatory compliance

Technical support

Education

High School Education or GED

Tools

ETQ

JDE

MES

MS Word

MS Excel

Minitab

Job description

Johnson & Johnson in Irving, TX is seeking a Quality Operations Technician to conduct QA inspections, support CAPAs, and help ensure GMP/compliance on the production floor.

You will collect quality metrics, perform investigations, and collaborate with QEs and other teams to resolve nonconformances while maintaining thorough documentation.

Experience with ETQ, JDE or MES is a plus; high attention to detail and ability to work independently are required.