Finished Goods Release QA Coordinator - Johnson and Johnson

Ethicon, a member of the Johnson & Johnson Family of Companies, is recruiting for a Finished Goods Release QA Coordinator 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 aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/.

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.

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.

Responsibilities:

• Prepares documentation that shows the results of tests performed.
• 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.
• Handle efforts among Sterilization Plant and Ethicon.

• Associate Degree from an accredited institution, preferably in a technical or science field with minimum four (4) years of experience within Quality Assurance Department is required; or Bachelor's degree in a science field with four (4) years of professional experience is required.
• One (1) year of Quality Assurance experience is preferred.
• Availability to work in 1 st , 2 nd , and/or 3 rd shift is required. Must be able to work overtime, weekends, and holidays.
• On Call ( Call in for work ) is required.
• Analytical/Problem Solving Skills are required.
• Availability to 10% travel requirement between Ethicon Locations, Domestic and/or international travel is required.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.careers.jnj.com .