Senior Supervisor Quality Engineer – Ortho Clinical Diagnostics – Raritan, NJ, USA
The Company Ortho Clinical Diagnostics (OCD) is a leading provider of in vitro diagnostic products and services, offering accurate, timely, and cost-effective solutions for screening, diagnosing, monitoring and confirming diseases. The company is a strong, highly competitive organization with approximately 3,800 employees worldwide, and sales, marketing and logistics on six continents. OCD was recently acquired by the Carlyle Group, a highly respected global asset management company, as an independent, freestanding company. With new leadership and accelerated investment in research and development, OCD is well positioned for growth as a leading player in the global diagnostics market, tapping into rising demand for sophisticated medical diagnostic products and services worldwide. The Career Potential We are committed to enabling diagnostics to fulfill its vital role in the continuum of care and its importance as the focus of healthcare changes from treating sickness to promoting wellness. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. You will have access to a broad and exciting array of experiences, opportunities and new directions at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That?s something we can all take pride in as we take this journey together. The Opportunity As the company transitions, we are seeking a Senior Supervisor Quality Engineer to provide oversight to Quality & Regulatory Compliance and Operations staff on all aspects of the biological manufacturing process controls including the label and packaging and cold chain requirements for the RhoGAM product line. You will utilize key Quality Engineering (QE) principles, tools, and practices to evaluate and develop processes that are aligned with the overall business and the Quality Policy. You will also provide support for equipment, process and process deviations occurring in the manufacturing process. Responsibilities: * Support manufacturing in addressing and writing quality events related to product release including non-conformance, product disposition, root cause investigation, laboratory OOS, and correctivepreventative action. * Utilize multifaceted industry and process excellence standards in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization. * A strong background related to interpersonal skills and provide direction, coaching and guidance to direct reports to meet business and personal development goals. * Assess, develop and implement business practices to improve compliance, cycle time, customer satisfaction and resource utilization. * Participate in Regulatory inspections to provide guidance on QA processes and systems. * Coordinating the review of production documentation to assure compliance with cGMPs, Work Instructions and SOP?s. * Direct and lead resources to ensure real time support to the RhoGAM process and to assure finished product is dispositioned in a timely manner. * Champion and facilitate the day-to-day issues and identify possible solutions to problems in accordance with cGMPs. * Demonstrate and utilize high level knowledge of manufacturing process and detailed knowledge of own work area. * Demonstrate knowledge of and ability to implement the CAPA process as per SOPs. * Actively supports CAPA to drive improvements and have the capability to perform effectivity assessments on those CAPA. Qualifications: The Individual * A minimum of a Bachelor’s degree in Biochemistry, Biology, Chemical Engineering or a related discipline is required. * A minimum of 5-10 years of experience in Quality, Regulatory andor Compliance in a highly regulated manufacturing environment (Diagnostics, Medical Device, PharmaceuticalBiologic, or Consumer) is required. * Knowledge of current and applicable GMP regulations is required. Knowledge of Quality System Regulations (QSR) and International Organization for Standardization (ISO) regulations required. * Knowledge or experience with CAPA and quality audits is required. Candidates who possess experience with statistical tools such as SPC and Sampling Plans are preferred. * Microsoft Office tools experience for communications, reporting and data analysis is required (Word, Excel, PowerPoint, etc.) use of Minitab is desired. * Report writing skills will be required. * This position will be based in Raritan, NJ. Join us on the Journey Let?s get started Apply today or refer a friend Ortho-Clinical Diagnostics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law. *QUAL #LI-POST #CB#
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