Janssen Ortho LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance Supervisor in Gurabo, Puerto Rico!

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 (http://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.

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

• Assure timely and reliable batch record review and disposition activities of raw materials, intermediate stages, bulk and finished products as per Supply Chain planning values. Establish cycle times then monitors and measures against standards.

• Ensure that assigned Batch Record Review process and product disposition outcomes are achieved aligned with Supply Chain goals and objectives.

• Ensure batch record review / continuous flow/ quarantine processes are executed in accordance with c-GMPs, Company Global Standards, Company Policies, Quality Agreements and current procedures.

• 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.

• Support the Senior Quality Assurance Manager to drive quality and personnel objectives to the established Company and QA Area/Department objectives.

• Provide technical mentorship and compliance support to Manufacturing and Packaging Operations. Take disciplinary actions with direct reports if applicable in alignment with Human Resources Policies and Procedures.

• Identify and evaluate related documentation including Investigations, Change Controls, and Protocols, Reports, Validation documents, Forms and Cleaning Validation Notifications to determine materials and / or product quality of a batch before conducting continuous flow into the next operational step.

• Assure equipment cleaning at risk documentation have been accurately documented in SAP System 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 is required, preferably in Science.

• Majors in Microbiology, Biology, Chemistry or related science are preferred.

• Certified Quality Auditor (CQA), Green Belt, Lean Manufacturing, and/or Kaizen certifications are highly preferred.

• At least six (6) years of experience in the Pharmaceuticals environment is required.

• Requires overall experience in Quality Assurance Unit.

• Knowledge of cGMP’s, record control specifications, and/or experience in regulatory inspections is required.

• 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, PowerPoint) is required.

• Knowledge in current systems as SAP, Compliance Wire, Documentation System, Investigation System (Track Wise), and LIMS is preferred.

• Proficiency in both languages English and Spanish (oral and written) is required.

• This position requires availability for working irregular shifts and weekends. Frequently requires working extended hours and might be required to work on holidays.

• Position requires up to ten percent (10%) of domestic travel.
  

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

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.careers.jnj.com (http://www.careers.jnj.com).