Johnson & Johnson Careers
Requisition ID: 1805699290W
‘Caring for the world, one person at a time ‘… inspires and unite the people of Johnson & Johnson, we embrace research and science- bringing innovative ideas, products and services to advance the health and well-being of people.
Janssen Pharmaceutical is part of Johnson & Johnson and responsible for bringing innovative medicines towards patients throughout the world.
The QA Specialist performs quality activities in support of new and existing products. The position has a great deal of interaction with many internal departments, including Engineering, Manufacturing, Purchase, Quality Control, and global Stakeholders. The QA Specialist performs a wide variety of activities to ensure compliance with applicable regulatory requirements; such as Maintain processes to ensure high quality products and compliance with current standards; documentation reviews; support quality audits; and data analysis
- Review, analyze, coordinate and/or investigate assigned customer complaints; consisting in proper documentation, inspection of product returns, investigation technical details, root cause analysis, risk assessment, and assist/lead associated CAPA investigations
- Ensure proper documentation and closure of each complaint in order to make and document sound regulatory reporting decisions/justifications.
- Develop a thorough understanding of the complaint database, and products in scope of the site.
- Assess of market impact of a complaint and escalate critical issues for proper disposition as necessary.
Reviews and analyzes customer complaint information for trending/risk analysis and corrective action and resultant effectiveness of action.
Support internal, external, and third-party audits.
- Support additional project team activities and/or investigations, and participate in process improvement activities and projects
Required skills and experience
- A Bachelor’s Degree in engineering, physical, biological, natural sciences or other related field is required.
- A minimum of 1 year of experience in quality in a pharma/medical device or other regulated industry is required. (Previous experience with complaints handling is preferred)
- Investigative & analytical critical thinking skills.
- CAPA root cause investigation execution, implementation of corrective and preventive actions to improve quality processes.
- Strong decision-making skills – able to make sound business decisions with sometimes limited information.
- Effectively manages work & time to produce desired outcomes (time management).
- Continuous interaction with global groups and the ability to collaborate with global customers is required.
- Strong written and verbal communication skills in English
- Desirable to have knowledge of statistical applications and auditing practices
Cilag AG (8562)