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.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Systems

Job Category:

Professional

All Job Posting Locations:

Anasco, Puerto Rico, United States of America

Job Description:

About Vision

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for QA Analyst II QS & Sterilization to be located in Añasco, PR.

The QA Analyst II QS & Sterilization is responsible for ensuring services, processes and facilities are in compliance with the organization’s Quality Assurance (QA) standards, international standards and government regulations. Contributes as a site technical expert for the sterilization process. Executes and coordinates validations, qualifications, and re-qualification's activities. Organizes cycle qualification and re-qualification studies for sterilization. Supports the development and implementation of quality systems based on business, regulatory and customer requirements. Adheres to environmental policy, procedures, and supports department environmental objectives.

You will be responsible for:

• Ensures compliance with company policies, procedures, and quality standards; as well as safety and environmental regulations.

• Develops solutions to database problems of moderate scope and complexity.

• Supports investigations/actions associated with non-conformances and CAPA, as directed by area manager.

• Reviews and revises change orders, change requests, and validation documents related to installation, operation, and performance qualification.

• Identifies issues and recommends appropriate corrective actions.

• Provides input to the development of validation protocols, reports and other related documents.

• Modifies and develops procedures for manufacturing operations, as result of the validations activities.

• Coordinates with the manufacturing areas, laboratories and other groups including suppliers to perform validation tests.

• Maintains the periodic review of validated systems schedules as specified.

• Presents data related to quality systems and sterilization performance to site management.

• Provides trainings as required.

• Provides support on activities requiring Quality review and approval as deemed necessary.

• Supports quality systems audits (internal and external) including preparations for inspections, follow-up support on investigations and actions taken to address audit findings.

• Participates as key member for site improvements projects related to quality and sterilization

Qualifications / Requirements:

• A minimum of an University/Bachelors Degree in Science or Equivalent is required.

• A minimum of 2 years of work experience in Sterilization and/or Laboratory

• Ethylene Oxide Sterilization knowledge, trainings, etc

• Laboratory experience

• Knowledge in microbiology

• Statistical Techniques GMP knowledge ISO13485-2016, CFR 820

• Strong communication skills

• Ability to write and speak in English and Spanish

• Technical writing skills

Johnson & Johnson is 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Business Alignment, Business Behavior, Collaborating, Communication, Compliance Management, Data Compilation, Data Quality, Data Savvy, Document Management, Execution Focus, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, Systems Analysis, Training People