QA Auditor, 3rd shift (2 openings)

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 effec...