Quality Analyst - Microbiologist
|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 - Microbiologistto work in the Fluids Release Laboratory to assure the outgoing quality of the Calibrators, Controls and reagents by executing analytical testing, executing microbiological test procedures to confirm product performance meets specifications and claims.
The Responsibilities: * Assures compliance to inspection readiness programs within the organization. * Person must be familiar with aseptic technique for microbiological work. * Works independently to complete microbiological product release tests by performing testing on the traditional media and the Rapid Milliflex. * Performs water and particle testing to assure proper environment is maintained. * Responsible for providing some analytical test results for product performance against specifications to make release decisions for the VITROS fluids. * Prepares product samples for multiple groups testing needs aseptically. * This individual will be responsible adhere to all quality, GLP, GMP and regulatory compliance policies. * Maintain equipment, reagents, and supplies. Will require limited work in a refrigerator. * Completes analysis of data using spreadsheets or LIMS to report testing results. Reviews data for accuracy and completeness. * Partners across Fluids Manufacturing to investigate and respond to specification failures or in response to observed trends. * Completes Laboratory Investigations, Non Conformance Records, or Quality Investigations in a timely manner. * Careful attention to detail and accuracy of work is essential. * An understanding of cGMPs and documentation in a regulated industry and experience in documentation protocols and procedures is a plus. * Planning and organization of daily workload, high affinity toward teamwork and demonstrated problem solving using innovative solutions * Perform raw material, intermediates and final product microbiology testing. * Good written and verbal skills are required to draft and review standard operating procedures * Provide analytical and manual dexterity to deliver accurate and reproducible results from complex microbiological methods. * May require over-time and occasional C or B shifts based on production needs and schedule.
* An Associates or Bachelor’s degree in Medical Technology, Chemistry, Biochemistry, andor related discipline is required. * Experience in a highly regulated manufacturing environment (Diagnostics, Medical Device, Pharmaceutical, or Consumer) is preferred. * Prefer a minimum 2 years of laboratory experience. * Knowledge of QA and QC principles and tools required. * Ability to multi-task, adapt to changes in daily workload, and contribute in a cross-functional team setting is desired. * Knowledge of current good lab practices, applicable GMP is required and familiarity with quality audits is recommended. * Some lifting is required, not to exceed 50 pounds. This position requires working in a lab setting which includes wearing personal protective equipment (PPE) and handling human samples. * Microsoft Office (Word, Excel, PowerPoint, etc.) tools experience for communications, reporting and data analysis is required. Join us on the Journey Let’s get started Apply today or refer a friend.