At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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.
What you will be doing:
The QA Complaint 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 Partners. The QA Complaint Specialist performs a wide variety of activities to ensure compliance with applicable regulatory requirements, and ensures the high quality of the marketed products and compliance with all standards; documentation reviews; support quality audits; and sophisticated data analysis.
Due to the diversity of contact points with Quality, Laboratory, Manufacturing, Engineering and Regulatory functions this role is especially well suited to build a solid understanding of the End-to-End development and lifecycle of pharma-products.
What impact you will also have:
* Review, analyze, coordinate and/or investigate assigned customer complaints.
* Inspection of product returns, investigation of technical details, and root cause analysis, risk assessment, and assist/lead associated CAPA investigations.
* Ensure accurate documentation and closure of each complaint in order to make and document sound regulatory reporting decisions/justifications.
* Develop a detailed understanding of the products and previously investigated complaints in scope.
* Evaluate the market impact of a complaint and escalate critical issues for immediate action.
* 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 projects.
Qualifications
We would love to hear from you, if you have the following essential requirements:
* A Master’s Degree or equivalent experience in engineering, physical, biological, natural sciences is required.
* Strong written and verbal communication skills in English.
* A minimum of 1 year of experience in quality in a pharma/medical device or other regulated industry 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.
* Continuous interaction with global groups and the ability to collaborate with global customers is required.
* Desirable to have knowledge of statistical applications and auditing practices.
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