Quality Operations Technician
Johnson & Johnson Innovative Medicine
Summary
Responsible for conducting technical quality assurance inspections, quality issue resolution, product containment, and supporting quality improvements for production processes and standards.
Job description
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).
Requirements
- High School Education or GED is required.
- Minimum of two (2) years of experience is required.
- 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.
- Ability to interpret a variety of instructions furnished in written, oral diagram, or schedule form.
- 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.
- 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.
- Medical Device manufacturing experience is preferred.
Company overview
Johnson & Johnson Innovative Medicine is the pharmaceutical division of Johnson & Johnson, leading the way in medical innovation with a relentless focus on bringing transformational treatments to patients worldwide. The company applies rigorous science and compassion to address the most complex diseases of our time, developing groundbreaking medicines across key therapeutic areas including oncology, immunology, neuroscience, and cardiopulmonary medicine. With deep expertise and global reach, Johnson & Johnson Innovative Medicine reimagines how devastating diseases are treated and cured, delivering hope and better care for millions of patients and their families. The organization pioneers the path from laboratory research to clinical application, championing patients every step of the way while maintaining an unwavering commitment to scientific excellence and patient-centered innovation.