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Quality

QA LAB SYSTEMS SPECIALIST

  • Título QA LAB SYSTEMS SPECIALIST
  • Função Quality
  • Sub função Quality Control
  • Categoria Analyst, Quality Control (P4 - N23)
  • Local San Lorenzo, Puerto Rico, United States
  • Postado
  • ID obrigatória 2406199045W
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Descrição

Ethicon, a member of the Johnson & Johnson Family of Companies, is recruiting for a QA Lab Systems specialist located in its manufacturing site at San Lorenzo, Puerto Rico.

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/. 

Responsibilities:

  • Data Analysis, Process Improvements and Decision Making:
  •   Exercise initiative, leadership and decision making to solve quality-related issues with other departments’ organization members and other Ethicon sites’ organization members.
  • Perform data analysis and recommend disposition of material.
  • Evaluate and make decisions on day to day Laboratory and or Manufacturing QA information systems related issues.
  • Evaluate and approve product control and disposition to determine if product is according to the requirements and Quality Systems Regulations.
  • Support Engineering and QA Departments in projects and validation activities.
  • Submit changes and support implementation of changes in the documentation system.
  • Support the effective implementation of programs that help improve the overall quality of product and process within area of responsibility.
  •  Utilize quality and statistical tools to recommend process improvements.
  • Manage and perform system transactions in Laboratory Management system (i.e., LIMS, Bluehill), such as but not limited to:
  • Corrections or adjustments.
  • User’s accounts.
  • New product codes or modification to existing product codes.
  • New product requirements or modification to existing requirements.
  • System validations.
  • System modifications.
  • Manage changes in the Adaptiv System.
  • Comply with all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001).
  • Document ETQ investigations for NR, CAPA, and Audits.  
  • Support internal / external audits and audits preparedness.
  • Support laboratory investigations documentation. Responsible for communicating business related issues or opportunities to next management level.
  • Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
  • Performs other duties assigned as needed.

Qualificações

  •  BS or BBA preferably in technical field.
  • At least two (2) years of work experience in regulated industry or four (4) years of professional experience.
  • One (1) year of experience managing and performing system transactions in laboratory management systems, preferred. 
  • Availability to work overtime, various work schedules, which may include 1st, 2nd, 3rd shifts and/or 12-hour daily shifts, including weekends and holidays.
  • Intermediate or higher computer skills and use of software application(s).
  •  Bilingual (Spanish & English)
  • ASQ CQT, preferred
  • ASQ CQA, preferred
  • Knowledge of QSR and ISO Standards.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.  

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.  

At Johnson & Johnson, we all belong. 

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