Qualifications: A BA/BS Degree or equivalent is required. A Degree in science concentration is preferred. 1-2 years laboratory or similar experience is required. Candidate must be willing to learn to operate maintain and troubleshoot Vitros 350 FS 51 3400 and 4600 analyzers. Candidate must have analytical knowledge required for production releases. Experience in QO LIMS or SAP is preferred. Careful attention to detail and accuracy of work are required. As an FDA regulated facility documentation is key to this position in order to meet regulatory requirements; therefore candidate must have an understanding of cGMPs and documentation in a regulated industry. Experience in documentation protocols and procedures are a plus. Candidate must have a proven track record of planning and organization of daily workload high affinity toward teamwork and demonstrated problem solving using innovative solutions. Having a working knowledge of computers and windows software is desired. Full understanding of quality control is expected. This position requires an individual who can multi-task adapt to changes in daily workload and priorities and operate in a cross-functional team setting. This position requires working in a BL2 lab environment which includes standing for long periods of time wearing personal protective equipment (PPE) and handling human samples. This position is located in Rochester NY. Shift details M-F 40 hrs/wk 2-week rotations between A shift (7am-3:30pm) and B shift (1:30pm-10pm). Responsibilities: Working in a laboratory environment supporting the manufacturing operations this person will be responsible for executing release testing and data analysis for release of product. Individual will run maintain and troubleshoot Vitros 350 FS 51 4600 and 3400XT analyzers. This position works in partnership with manufacturing Operations Product Support and other technical support groups to ensure Quality and customer expectations are met prior to final release of the product. The individual will execute Vitros testing following Test Designs and analyze data for the release of product. Routinely interacts with data management systems such as LIMS SAP Document Management Systems (Windchill) and Non-Conformance & CAPAs (QERTS).
Quality Analyst I
