Quality Assurance Auditor (Third Shift) 1of 2

Janssen Ortho LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance Auditor (third shift) in Gurabo, PR.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information. We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

Growing on a diverse company culture, celebrating the uniqueness of our employees, and committed to inclusion. Proud to be an equal opportunity employer.

RESPONSIBILITIES:

•  Be accountable for ensuring the compliance with all material specifications, current Good Manufacturing Practices, approved written procedures, Company Global Standards and Quality Agreements during batch record review and continuous flow processes related to the manufacturing and/or packaging of a product, comprehending raw materials, drug substances, WIPs, finished product, intermediate stages and packaging components.
•  Collaborate with Operations, Logistics, Warehouse, Technical Operations, Site Services, Quality Assurance and QC Laboratories to solve potential compliance issues in a proactive way in order to deliver product on time. Make the appropriate recommendations and decisions to prevent process and/or product deviations.
•  Review batch records and perform continuous flow of the WIP’s, Intermediate Stages, Finished Good and/or Raw Materials (API and Excipient) batches to ensure compliance, before a batch is released, distributed, rejected.
•  Identify and evaluate related documentation such as Investigations (Events and Deviations), Change Controls, and Protocols, Reports, Validation documents, Forms and Cleaning Validation Notifications to resolve materials and / or product quality of a batch before conducting continuous flow into the next operational step.
•  Assure prior that all regulated items established by current procedures, current specifications, quality agreements or customers are considered. Ensure all related samples for the specific stage have been taken and been indicated accordingly in SAP System and/or LIMS.
•  Assure equipment cleaning at risk documentation have been properly documented in SAP as a flagging item for the Order Release Group.
•  Support the Cycle time reduction in batch records review and release. Assure that products are approved on time and to minimize product back-order situations related to Product Disposition performance.
•  Participate in GEMBA and Kaizen Teams to avoid back-orders and deliver the product on a timely manner.
•  Provide immediate actions and support in the timely resolution of quality and compliance matters that may include but not limited to product segregation, product recalls and product approval/rejection.
•  Update SAP System with batch status change of a product under investigation that should not be further processed that may require physically segregation/ identification accordingly.