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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:

Gurabo, Puerto Rico, 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 QA Auditor, 3rd shift ( 2 openings available) to be located in Gurabo, Puerto Rico.

The QA Auditor is accountable for ensuring under the direction of the QA Supervisor for the compliance with all material specifications, current Good Manufacturing Practices, effective written procedures. Reviews batch records, performs continuous flow/quarantine processes and product disposition of the WIP’s, Intermediate Stages, Finished Good and/or Raw Materials (API and Excipient) batches to ensure compliance. Collaborate with Operations, Logistics, Warehouse, Technical Operations, Site Services, Quality Assurance and QC Laboratories to resolve potential compliance issues in a proactive way in order to deliver product on time. Responsible to make the appropriate recommendations and decisions to prevent process and/or product deviations.

Key Responsibilities:

+ Review batch records thoroughly, perform continuous flow and quarantine assessments, and coordinate product disposition for WIPs, intermediates, finished goods, and raw materials (API and excipients) to ensure compliance with specifications and cGMP standards.

+ Collaborate with cross-functional teams—Operations, Logistics, Warehouse, Technical Operations, Site Services, Quality Assurance, and QC Labs—to proactively identify, address, and resolve compliance issues.

+ Make informed, data-driven recommendations and decisions to prevent process deviations, product non-conformances, and quality issues, bringing up critical concerns promptly.

+ Document quality assessments, deviations, investigations, and corrective actions meticulously, ensuring full regulatory and internal compliance.

+ Support continuous improvement by identifying process gaps, inefficiencies, and risks, and proposing effective corrective and preventive actions.

+ Keep current with industry regulations, standards, and internal policies to uphold the highest quality standards.

Qualifications

Education:

+ This position requires a bachelor degree on Science with a major in Microbiology, Biology, Chemistry or related science.

Experience and Skills:

Required:

+ A minimum of 2 years of work experience in a regulated industry.

+ Knowledge on Training System, Documentation System, Investigation and Change Control System, eLIMS.

+ Must exercise judgment on the resolution of final release problems to meet company standards for quality, cost and critical success factors.

Other:

+ Requires working the third shift, extended hours, holidays and/or weekends.

+ The position requires employee to be proficient in Spanish and English and must have excellent ability to technical writing in English and Spanish.

+ This position may require up to 10% of domestic and/or international travel

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills: