Location: Gurabo, PR
Company: Johnson And Johnson
and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at and follow n Ortho is part of the Janssen medical Companies.
Growing on a diverse company culture, celebrating the uniqueness of our employees, and committed to inclusion. Proud to be an equal opportunity employer. Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity! Responsibilities: 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, Manufacturing Sciences and Technology, Make Asset Management, 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. Qualifications A bachelor's or higher degree in science with a minimum of two (2) years of related experience in the medical, consumer, or medical devices industry; or an associate degree in science with at least five (5) years of related experience. Focus degree in Microbiology, Biology, Chemistry, or related science are preferred.
Certified Quality Auditor (CQA), Green Belt, Lean Manufacturing, and/or Kaizen certifications are highly preferred. Knowledge or experience in Oral Solid Dosage forms manufacturing process is required. Knowledge in documents such as safety rules, Standard Operating Procedures, Work instructions, investigations, validation reports, and protocols is required. Proficiency with Microsoft Office tools (Word, Excel, Power Point) is required. Knowledge in SAP, Learning Management System, Documentation System, Investigation System, and/or LIMS is preferred.
Proficiency in both languages English and Spanish (oral and written) is required. Availability to work the third shift, including irregular shifts, weekends, overtime, and holidays is required. Must exercise judgment on the resolution of final release problems to meet company standards for quality, cost, and critical success factors. This position requires up to ten percent (10%) of domestic travel. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual 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.
Quality Assurance (QA) jobs involve the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. The primary goal is to identify defects and issues before the product reaches the customer, thereby ensuring customer satisfaction and maintaining the reputation of an organization. QA roles often require attention to detail, strong problem-solving skills, and a good understanding of industry-specific regulations and standards. These jobs can vary widely, from software testing to food safety inspection, but they universally function as a critical checkpoint in the production and delivery process of goods or services.
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Quality Assurance (QA) jobs entail roles focused on ensuring that products or services meet established standards and customer expectations. People in QA positions are responsible for designing testing processes, creating test plans, identifying defects, and preventing defects by examining the production process. They aim to enhance product reliability and actively work to maintain quality consistency. QA roles often require keen attention to detail, strong problem-solving skills, and an understanding of both product specifications and customer needs. QA is an integral part of product development and maintenance, bridging the gap between the manufacturing processes and the end users to ensure a satisfactory experience.
Quality Assurance (QA) jobs involve the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. The primary goal is to identify defects and issues before the product reaches the customer, thereby ensuring customer satisfaction and maintaining the reputation of an organization. QA roles often require attention to detail, strong problem-solving skills, and a good understanding of industry-specific regulations and standards. These jobs can vary widely, from software testing to food safety inspection, but they universally function as a critical checkpoint in the production and delivery process of goods or services.
