Quality Analyst 1

Ortho-Clinical Diagnostics New York , NY 10007

Posted 4 months ago

The Career Potential

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.

The Opportunity

Ortho Clinical Diagnostics is recruiting for a Quality Analyst 1 located in our Operational Quality Laboratories in Rochester, NY.

The Responsibilities

  • Works independently to execute release testing following a LIMS test design and analyzing the test results following standard operating procedures.

  • Completes analysis of data using spreadsheets and LIMS. Reviews data for accuracy and completeness while escalating any observed issues.

  • Maintains analyzers, reagents, and laboratory supplies. Will require limited work in a freezer and refrigerator.

  • Partners with Product Support and Quality groups to investigate and respond to atypical data.

  • Completes Laboratory Investigations, Non Conformance Records, or Quality Investigations, as needed and in a timely manner.

  • Assures compliance to inspection readiness programs within the organization.

  • Careful attention to detail and accuracy of work is essential.

  • An understanding of cGMPs and documentation in an FDA regulated industry and experience in documentation protocols and procedures.

  • Planning and organization of daily workload, high affinity toward teamwork and demonstrated problem solving using innovative solutions

  • May require over-time and occasional B shifts based on production needs and schedule.

The Individual

  • A Bachelor degree (B.A. or B.S.) degree or equivalent is preferred. A degree with a science concentration is preferred

  • Strong written and verbal communication skills with attention to detail.

  • Ability to multi-task, adapt to changes in daily workload, and contribute in a cross-functional team setting is desired.

  • Planning and organization of daily workload, high affinity towards teamwork, and problem solving skills is needed.

  • An understanding of cGMPs and documentation in an FDA regulated industry and experience in documentation protocols and procedures is a plus.

  • 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.

  • Some lifting is required, not to exceed 50 pounds.

  • Microsoft Office (Word, Excel, PowerPoint, etc.) tools experience for communications, reporting and data analysis is required.

  • This position works an A shift, with potential for coverage needed on a B shift. Overtime including weekend shifts may be required on occasion. This position is located in Rochester, NY and does not offer any relocation support.

  • Work visa sponsorship is not available for this position




For this position we will not sponsor applicants for work visas.

Equal Opportunity

Ortho Clinical Diagnostics believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. Ortho Clinical Diagnostics is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their job related duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at orthorecruiting@orthoclinicaldiagnostics.com

Supplemental Poster

Pay Transfer Notice

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Quality Analyst 1

Ortho-Clinical Diagnostics