Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. 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. There is no limit to the experiences, opportunities and new directions you will have access to here 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.

Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It's who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.

As the company continues to grow, we are seeking a SPQC Quality Analyst I. This SPQC Quality Analyst I position is located in our Operational Quality Laboratories in Rochester.The schedule will be B shift (2:00pm -10:30pm). Tuesday through Saturday.

This position is located in Rochester, NY.

• Executing release testing and data analysis for release of product.

• Individual will run, maintain, and troubleshoot Vitros 350, FS 5, 1, and 4600 analyzers.

• Work 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 (OTIS), and Non-Conformance & CAPAs (QERTS).

• 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 run, maintain and troubleshoot Vitros 350, FS 5, 1, and 4600 analyzers.

• Candidate must have analytical knowledge required for production releases.

• Experience in OCD 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 demonstrated 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 function in a cross-functional team setting.

• This position requires working in a lab setting which includes standing for long periods of time and wearing personal protective equipment (PPE).

• Candidates are required to work in a BL2 Lab and handle human samples.

EOE/AA Disability/Veteran