Quality Analyst II
|Organization:||Ortho Clinical Diagnostics|
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 aQuality Analyst IIto assure the outgoing quality of the Calibrators, Controls and reagents by reviewing analytical release data, providing input into the troubleshooting investigations and confirming the product performance meets specifications and claims.
The Responsibilities: * Provides leadership andor technical support to Product Support, PPL, Quality Regulatory and Compliance, Validation Engineers and Operations Lab staff. * Assures compliance to inspection readiness programs within the organization. * Determines both data-based and risk-assessment-based decisions for setting accuracy of uTIP assays and Calibrator and Control fluids. * Utilizes industry and process excellence standards (PEx) in daily quality operations, when addressing complex production issues. * Initiate process improvements using their strong background in quality, GLP, GMP and regulatory compliance. * Monitors product performance (Precision, Accuracy, Linearity). * Escalates product and process concerns. * Leads and supports teams to investigate quality issues (failure investigations) that resolve complaints and nonconforming products. * Works independently to issue and investigate quality, and compliance related non-conformances using a systematic approach to problem solving, conducting risk analyses and ensuring appropriate corrective and preventative actions to drive improvements.
* A Bachelor's degree in Medical Technology, Chemistry, Biochemistry, andor related discipline is required. * A minimum of 5 years of experience in a highly regulated manufacturing environment (Diagnostics, Medical Device, Pharmaceutical, or Consumer) is required. * Ability to problem solve and make risk based decisions on VITROS product performance that will maintain calibration traceability and product claims without adversely impacting clinical decisions. * Knowledge of current good lab practices, applicable GMP is required and familiarity with quality audits is recommended. * The ability to think independently while effectively prioritizing and managing multiple project workloads is required. * Excellent written and oral communication skills, including presenting technical reports and defending release decisions to cross-functional groups is needed. * The ability to participate in complex, technical and cross-functional projects is required. * Microsoft Office (Word, Excel, PowerPoint, etc.) tools experience for communications, reporting and data analysis is required. Preferred: * Experience with Six SigmaProcess Excellence tools, training andor certification is preferred. * Experience in a hospital laboratory-like environment is beneficial. * Ability to understand the implications of making VITROS performance decisions and their effect on the health will be needed. * Experience with VITROS data analysis in QDIS-R LIMS is preferred. * Ability to interface with multiple applications (i.e. QERTS (nonconformance) and OTIS (change control) is preferred. * A working knowledge of the testing, data analysis and evaluation of value assignments for uTIP assays and calibrator control fluids allows for final data review, disposition and release to the ADD. * The ability to manage quality documentation utilizing QERTS records to initiate NCs, resolve CAPAs, contribute to DRAs and aid in the closure of quality records is required. * Proficiency with the OTIS change control process allows planning, execution and completion of a project to expedite change and minimize customer disruption.