Scientist 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:

As the company continues to grow, we are seeking a Scientist 1 located in Rochester, NY.

The Responsibilities:

  • Assures compliance to inspection readiness programs within the organization.

  • This individual will be responsible to initiate process improvements using their strong background in quality, GLP, GMP and regulatory compliance.

  • Monitors Reference Assay performance (Precision, Accuracy, Linearity) and is responsible for initially addressing or if needed, escalating reference testing issues and process concerns.

  • Assures compliance to inspection readiness programs within the organization.

  • Responsible for providing analytical test results for product performance against specifications to make release decisions for the VITROS fluids.

  • This individual will be responsible adhere to quality, GLP, GMP and regulatory compliance policies.

  • Works independently to complete product release tests by performing testing on multiple types of equipment including: pH meter, UV-VIS spectrophotometry, Flame photometer, Atomic Absorption, RIA, HPLC, GC, Chloridometer, and CO2 Meter in compliance with procedures.

  • Maintain equipment, reagents, and supplies. Will require limited work in a freezer or refrigerator.

  • Completes analysis of data using spreadsheets or LIMS to report testing results. Reviews data for accuracy and completeness.

  • Partners across Fluids Manufacturing to investigate and respond to specification failures or in response to observed trends.

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

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

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

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

  • Perform reagent, standard material, intermediates and final product testing

  • Calibrate, troubleshoot and maintain laboratory instrumentation and equipment

  • Good written and verbal skills are required to draft and review standard operating procedures

  • Participate in laboratory investigations, validations and verifications

  • Provide analytical and manual dexterity to deliver accurate and precise results from complex analytical methods.

  • Performs housekeeping to ensure the laboratory is continuously maintained in a safe, orderly and compliant condition. Decisions are made on product performance based on tests run by technicians.

  • Mathematically inclined to work up chemical calculations for reagent preparation.

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

  • With a working knowledge of quality control, monitor assay quality control performance and participates/leads quality control reviews for analytical tests.

The Individual:

  • Minimum Associates degree in Chemistry, Biology, Medical Technology or related field is required. A Bachelor degree (B.A. or B.S.) degree or equivalent is preferred.

  • Minimum 2 years of laboratory experience.

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

  • Knowledge of QA and QC principles and tools required.

  • Basic operating knowledge of typical laboratory automated equipment. Experience with spectrophotometers, HPLC and GC is preferred.

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

  • Manual dexterity for handling instruments, repetitive motions and standing for long periods of time is required.

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

  • Some lifting is required, not to exceed 50 pounds. This position requires working in a lab setting which includes wearing personal protective equipment (PPE) and handling human samples.

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

  • Knowledge of current good lab practices, applicable GLP/GMP requirements is recommended.

  • Some lifting is required, not to exceed 50 pounds. This position requires working in a lab setting which includes wearing personal protective equipment (PPE) and handling human samples.

  • 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

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Scientist 1

Ortho-Clinical Diagnostics