Finished Goods Release QA Coordinator

Johnson & Johnson Innovative Medicine•San Lorenzo, PR

4d•Onsite

About The Position

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 Control Job Category: Professional All Job Posting Locations: San Lorenzo, Puerto Rico, United States of America Job Description: About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech About Surgery 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 the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. 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 Finished Goods Release QA Coordinator. Purpose: Under the direction of the Quality Manager or Quality Team Leader and with the objective of maintaining high-quality standards, will coordinate the final product release process and maintain compliance with the regulatory requirements. Engaged in the Quality Assurance operation in accordance with the QSR, ISO and Ethicon written inspection specification and quality standards. Analyses product related information to assure that products comply with established specifications. Prepare reports (using the computer system), as assigned. Completes record of inspection results, acceptance, rejection and disposition.

Requirements

An Associate Degree (in a science or technical field is preferred) with a minimum of four (4) years of experience within Quality Assurance Department is required; or Bachelor’s degree in science with four (4) years professional experience is required.
10% travel requirement between Ethicon Locations, Domestic and/or international travel is required.
Availability to work overtime, various work schedules, which may include 1st, 2nd, 3rd shifts and/or 12-hour daily shifts, including weekends and holidays is required.

Responsibilities

Prepares documentation that shows the results of tests performed and prepare custom reports on results.
Review and complete transactions such as, but not limited to, batch records, Sterilization Certificates of Processing and appropriate records retention in Manufacturing and Quality Systems to release Finished Goods products.
Advise about any non-conformance related to the QA inspection and test methodologies.
Generate the Non-Conformance Report (NC) to the impacted Department.
Evaluate the precision and accuracy of products, production equipment, and/or testing equipment.
Use LIMS and JDE software to document the inspection results and disposition to product prior to release.
Collect or oversee the collection of Finished Goods and Retain samples at the sterilization site when needed for testing and for evaluation.
Performs data analysis and recommends disposition of material.
Segregate Finished Goods samples and Retain Samples according to the requirements.
Generate Certificate of Analysis (COA) as per Client’s and other Plants Requests.
Support Sterilization Diversion activities.
Work with two different Sterilization Suppliers and assists as required.