Exp Anlst Quality Assurance

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:

About Innovative Medicine

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

We are searching for the best talent for a Quality Assurance Batch Release Specialist II to join our Team! This is an onsite/hybrid role.

Purpose

The Quality Assurance Batch Release Specialist II, is an exempt level position with responsibilities for providing quality attributes over a wide range of activities and projects in the CAR-T facility to support clinical and commercial efforts to release material for human use.

Responsibilities

• Responsible for disposition of final drug product.   

• Review released documentation for all manufacturing activities executed in accordance with Good Documentation Practices (GDP).

• Work in a team based, cross-functional environment to complete tasks required to meet business objectives.

•    Author and review release documentation.

• Collaborate with (cross) functional departments to resolve issues related to batch review/release, investigations, and receipt of QC test results to allow for timely release of final product batches according to department and business plan in a complex fast paced supply chain organization.

•     Perform duties/tasks under minimal supervision according to standard operating and manufacturing procedures and demonstrate ability to attain resources and information from established internal contacts.

•   Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements, as well as according to state and federal regulatory requirements.

•       Strive to reduce non-conformances in supported areas by dedicatedly driving compliance.

• Ensure readiness of records for regulatory inspections and internal audits.

Qualifications/Requirements

• Minimum of a Bachelor’s degree in Science, Engineering or equivalent technical field is required  

• Minimum of 2 years of relevant experience within Manufacturing, Quality Assurance or Batch Release in either the pharmaceutical or biotech industries

Skills/Experience:

• Knowledge and solid understanding of current Good Manufacturing Practices (cGMP) regulations and FDA/EU guidelines

• Highly organized, with proven attention to detail and ability to follow procedures with minimal supervision. Knowledge of cGMP/GTP regulations and FDA

• Strong social skills, willingness to take initiative, and capability of working in a collaborative team environment.

• Proficient verbal communication skills, with the ability to effectively summarize and present results

• Ability and flexibility to work 10-hr shifts between the operational hours of 8am-7pm, and weekends or other shifts, required.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion,