QA Analyst I
Ortho Clinical Diagnostics, Johnson Johnson's Family of Companies, is recruiting for a Quality QA Analyst 1 located in our Fluids facility in Rochester, NY.
Ortho Clinical Diagnostics serves the transfusion medicine community and laboratories around the world. We're a leading provider of total solutions for screening, diagnosing, monitoring and confirming diseases early, before they put lives at risk. Our single focus is to help hospitals, laboratories and blood centers worldwide deliver results that help patients experience a better quality of life.
Working in a laboratory environment and supporting the fluids manufacturing operations, this person will be responsible for testing raw materials, analyzing and documenting data, then presenting the findings.
The QA Analyst I will analyze and review data for accuracy and trends against specifications utilizing hospital based medical equipment. Maintain quality assurance programs, procedures, and controls ensuring that the performance and the quality of product conform to company standards. Will assist in conducting investigations related to product or process issues. Support formulations department with analytical testing to determine if adjustments to the formulation are needed. Develop solutions to problems with limited scope and complexity. Requires use of application of basic standard principles, theories, concepts and techniques. May work with cross-functional teams on new product development, and write, maintain and update appropriate SOPs. Accountable for conducting duties in compliance with cGMPs/QSR/ISO, company policies and procedures, safety and environmental requirements. Accountable for timely and accurate testing, analysis, and documentation. Accountable for notifying management or designee of any specification results / abnormal trends in a timely manner. Accountable for documenting and reporting all non-conformances / errors to management immediately. Accountable for ensuring efficiency and productivity of teams and its continuous improvement. Decisions are made on product performance based on tests and the analysis of the data. Failure to meet these criteria could lead to an incorrect decision on product quality.
Qualifications
A High School diploma or equivalent is required; BA/BS degree is preferred plus 3 years of related experience is required. Knowledge of laboratory processes and procedures is required. The ability to operate, troubleshoot and maintain required equipment, instrumentation and analyzers is required. Careful attention to detail and accuracy of work is essential. Strong data analysis skills are required. This position requires an individual who can multi-task, adapt to changes in daily workload and priorities, and function in a cross-functional team setting. Ability to lead small technical teams is preferred. The ability to use a systematic approach to solving problems is required. Technical proficiency, including Microsoft Outlook is required. This position requires working in a lab setting which includes handling human samples, standing for long periods of time and wearing personal protective equipment (PPE). Some lifting, not to exceed 50 pounds is required. Manual dexterity for handling instruments and repetitive motions is required. This position requires periodic overtime and the ability to work B (2:30pm-11:00pm) and C (11:00pm - 7:30am) shifts when needed in addition to some OT on weekends. This position is located in Rochester, NY.
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