QA Specialist II

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:
Raritan, New Jersey, United States of America

Job Description:

Janssen Supply Groups is recruiting for an QA Specialist II, located in or Raritan, NJ!

This position is Tuesday to Saturday first shift 8:00AM - 4:30PM.

This is an onsite position.

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

As a QA Specialist II you will release incoming patient apheresis material for CAR-T treatment manufacturing.

Come join our fast-paced and dynamic team to deliver this cutting-edge therapy to our patients.

Key Responsibilities:



* Partner with Operations teams to support production activities related Advanced Therapy products in a cGMP manufacturing facility.


* Perform review of production documentation and provide guidance to resolve quality related manufacturing issues and/or documentation discrepancies


* Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner.


* Support change management processes including formal change controls by evaluating the proposed changes, assessing impact, and providing quality input on implementation plans.


* Author and revise Quality departmental documents.


* Review and approve controlled documents including standard operating procedures, master batch records, work instructions, protocols and reports, and technical studies.


* Participate in continuous improvement activities.


* Perform regularly scheduled oversight of manufacturing activities in a controlled clean room environment.


* Supports site inspections and inspection readiness activities.

Ensure the site is audit ready.


* Support data integrity efforts.


* Maintain a sufficient inventory of materials necessary for daily functions.


* If necessary, support adjacent QA groups with record issuance and management.


* Other duties may be assigned as necessary.

Qualifications

Education:


* A minimum of a Bachelor's Degree in a ...