QA AUDITOR (THIRD SHIFT)

Janssen Ortho LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a QA Auditor (third shift), to be located in Gurabo, PR.
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.
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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 Quality Control (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 work in progress (WIP’s) bulks, Intermediate Stages, Finished Goods 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 Qualifications A minimum of a bachelor’s or higher degree in science is required.
Focus degree in Microbiology, Biology, Chemistry, Engineering, or related sciences are preferred.
A minimum of two (2) years of related experience in the pharmaceutical, consumer, or medical devices industry.
Certified Quality Auditor (CQA), Green Belt, Lean Manufacturing, and/or Kaizen certifications are highly preferred.
Knowledge or experience in Oral Solid Dosage forms manufacturing or packaging 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, PowerPoint) is required.
Knowledge in SAP, Summit Learning Management System, TruVault Documentation System, TrackWise and/or Comet Quality System, and/or Laboratory Information Management Systems (LIMS) is preferred.
Proficiency in both languages English and Spanish (oral and written) is required.
Availability to work 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, 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.
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