Quality Analyst

Quality Analyst 6 Months Rochester NY, 14626

PAR QA Analyst I - A or B Shift Mon-Fri Client is recruiting for a Quality Analyst 1 located in our Operational Quality Laboratories in Rochester, NY. This position requires flexibility between A shift (7:00am-3:30pm) and B shift (1:30pm-10:00pm) depending on business need.

Client 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  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 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, 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.

Position requires flexibility between A shift (7am-3:30pm) and B shift (1:30pm-10pm). Shift rotation: 2 weeks on A, then 2 weeks on

B.

A BA/BS degree or equivalent is required; a degree with a science concentration is preferred. Previous laboratory or similar experience is required. Candidate must be willing to learn to operate, maintain and troubleshoot Vitros 350, 4600, and 3400XT 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.