QA Analyst

Job Summary:

• 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.

Education:

• A BA/BS degree or equivalent is required; a degree with a science concentration is preferred.
• Previous laboratory or similar experience is required.

Qualifications:

• 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.

Work Environment:

• 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.