Quality Operations Technician

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

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

Business Enablement/Support

All Job Posting Locations:

Irving, Texas, United States of America

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for Quality Operations Technician.

Purpose:

Responsible for conducting technical quality assurance inspections, quality issue resolution, product containment, and supporting quality improvements for production processes and standards.

You will be responsible for:

Supports Quality Operation functions including: CAPA/NC initiatives, Quality “presence” on the manufacturing floors, and proactive GDP and Data Integrity.

Assist with data collection for quality metrics, quality improvement initiatives, CAPAs, NCs, or Quality Systems.

Conduct failure investigations and root cause analysis.

Perform data searches and transactions within MES, JDE, and EtQ.

Partner with QEs and business partners (and other NC “owners”) providing support with NC process, investigations, and/or corrective actions.

Actively influence the team and other fellow workers as role model for Collaboration and Teamwork

Provide BOP, Internal audit and external audit support.

Read and interpret drawings, QCIC's and test methods and perform the tasks defined therein.

Develop, prepare and report technical information to identify, segregate and disposition product through the nonconforming system.

Support periodic review activities related to Quality Operations.

Backup support for finished good release trace activities.

Support quality improvement related projects

Demonstrate independent understanding and application of core GMP fundamentals, including but not limited to: Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs).

• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

Qualifications / Requirements:

EXPERIENCE AND EDUCATION*

High School Education or GED is required.

Minimum of two (2) years of experience is required.

SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

Professional certifications (CQAI, CQA or others) are desired.

Green Belt Certification preferred.

Project deployement 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.

Computer experience utilizing such programs as JDE, MS Word and MS Excel, Minitab for project initiatives and problem solving.

Ability to interpret a variety of instructions furnished in written, oral diagram, or schedule form.

Medical Device manufacturing experience is preferred.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

#LI-Onsite

Required Skills:

Preferred Skills:

Agility Jumps, Compliance Management, Curious Mindset, Customer Centricity, Detail-Oriented, Document Management, Factory Acceptance Test (FAT), Persistence and Tenacity, Process Oriented, Professional Ethics, Quality Control (QC), Quality Control Testing, Quality Standards, Quality Systems Documentation, Regulatory Compliance, Technical Support