SPECIALIST QA PHARMA COMPLAINTS

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.
Learn more at https://www.
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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 of 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 Masters’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 What type of mark will YOU make?  By joining Johnson & Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls.
And with our commitment to be the world’s healthiest workforce you can strengthen your body as well and your mind.
When you work at Johnson & Johnson you can touch over a Billion lives worldwide every day.
And when you apply your talent to our collective purpose there’s no end to the lasting impact we can make together.
And that changes everything.
Diversity, Equity & Inclusion at Johnson & Johnson means "YOU belong"! For more than 130 years, diversity, equity & inclusion have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.
Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.
That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued, and every one of our people feels that they belong and can reach their potential.
No matter who they are.