Quality Assurance Specialist (Two openings)

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 Assurance

Job Category:
Professional

All Job Posting Locations:
Durham, North Carolina, United States, Wilson, North Carolina, United States of America

Job Description:

Johnson & Johnson is currently recruiting for Quality Assurance Specialists (Two openings)! This position is located in Wilson, NC.

This role requires a fully onsite Monday-Friday schedule.

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/.

Essential Job Duties and Responsibilities

This position is responsible for ensuring compliance with regulatory requirements and company policies following current Good Manufacturing Practices, Johnson & Johnson Policies and internal procedures through the following duties and responsibilities:


* Ensure the site validation program has been developed and maintained in compliance with all regulatory and corporate requirements and Master Plans.


* Works with the applicable qualification teams representing Quality Assurance in the requirement, design review, construction, qualification and leveraging documentation strategies, cleaning development/validation and implementation of project. 


* Review and approve commissioning and qualification documentation, including URS (User Requirements Specifications), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols and reports, SOP’s, Work Instructions and any other technical document.


* Review and approves validation protocols and reports (analytical, cleaning, process, etc.)


* Provide quality oversight for C&Q and validation execution activities to ensure compliance with GMP, FDA, EMA, and other regulatory requirements.


* Support the development and implementation of C&Q and validation plans, ensuring alignment with project timelines and deliverables.


* Perform QA reviews of system impact assessments and categorization of equipment and utilities.


* Ensu...