01 feb
Kenvue
Xico
Come work at the forefront of science - and help the brands you grew up with grow and evolve into the next generation.
Job Description - Quality Assurance Specialist (2507030287W) Quality Assurance Specialist To be based of work located at Mexico.
Reporting directly to the Quality Assurance Sr Supervisor.
Who We Are At Kenvue, we realize the extraordinary power of everyday care.
Built on over a century of heritage and rooted in science, we're the house of iconic brands - including NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSON'S, and BAND-AID that you already know and love.
Science is our passion; care is our talent.
Our global team is made by 22,000 diverse and brilliant people, passionate about insights,
innovation and committed to deliver the best products to our customers.
With expertise and empathy, being a Kenvuer means to have the power to impact the life of millions of people every day.
We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you!
Join us in shaping our future – and yours.
What You Will Do? Establishes and maintains quality assurance programs for External Manufacturers (EM), procedures and controls, ensuring that performance parameters of both the products and quality system elements are continually measured to drive improvement initiatives.
Administers the change control program and manages local procedures and specifications in the document control system.
Leads efforts to comply with company policies, procedures, and quality standards, as well as safety and environmental regulations.
Develops solutions to database problems of advanced scope and complexity.
Generates, identifies, and suggests improvements in significant performance trends.
Reports them to management and appropriate cross-functional teams.
Ensures appropriate technical assistance in the use of information mapping technology.
Releases batches once it has been determined that all compliance and procedural requirements have been met.
Investigates, tracks and trends customer complaints and provides complaint data for quality reports including annual drug product reviews, and monthly or quarterly complaint reports.
Key Responsibilities: This position will be responsible for the management of External Manufacturers (EMs) sites with different manufacturing technologies located in Mexico. Manage troubleshooting with the EMs. Provide support to Investigation, CAPAs, and Change Controls at the EMs quality system. Perform annual Quality Reviews with EMs Sites.
Provide support and identify improvement opportunities internally (Kenvue Base Business) and at External manufacturing sites. Support Audit readiness program at the EMs site. Monthly Metrics Report. Be part of areas meetings and war rooms. Complaint Management. Audit action Plans management. Support EM Validation Process. Execute External site oversight presentational visits. Supplier Qualification process. What We Are Looking For? Education: Graduation in Pharmacy/Engineering/Chemistry or other correlate area. Required Qualifications: Advanced Spanish 5 years minimum experience in Quality or other correlated areas related to Pharma/Medical Devices and Cosmetic Industries Audit Experience/Qualification (ISO, ASQ, ANVISA, DIGEMID, COFEPRIS, ANMAT) Preferred Skills and Experience:
Statistical knowledge Able to propose innovative solutions in a dynamic environment Technical Writing Skills Skills to communicate issues to upper management Strong Problem-solving skills Presentation skills What's In It For You Competitive Benefit Package Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More! Learning & Development Opportunities This list could vary based on location/region Kenvue is proud to be 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, or protected veteran status and will not be discriminated against on the basis of disability.
If you are an individual with a disability, please check our page for information on how to request an accommodation.
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