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QA Analyst I-2

Company name
Ortho-Clinical Diagnostics, Inc.

Location
Rochester, NY

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Job Description
The Company\r\r\r\r\r\r\r\r\r\rOrtho Clinical Diagnostics (Ortho) is a global leader of in vitro diagnostics.  Ortho serves two primary industries in the medical field: clinical laboratories, by producing platforms and assays that test for a variety of diseases, conditions, and substances; and immunohematology, by providing the means to ensure blood transfusion recipients receive appropriate and compatible blood.With a history of more than 75 years, Ortho is a pioneer in life-impacting advances in diagnostics. Worldwide across hospitals, hospital networks, blood banks and labs, Ortho’s high-quality products and services enable health care professionals to make better-informed treatment decisions. Headquartered in Raritan, NJ, Ortho Clinical Diagnostics has approximately 4,300 employees serving customers in more than 120 countries.Ortho is recruiting and retaining the best and brightest around the world. People, who are performance driven, want to make a difference and who help Ortho grow their leadership position in a changing marketplace. The power to reimagine starts with empowered people, who are empowered to grow and given the chance to succeed in ways they hadn’t thought possible before.Ortho’s purpose is simple: to improve and save lives with diagnostics. They do that by reimagining what’s possible. It’s what defines them. It’s the Ortho difference.Ortho is an independent company, sponsored by The Carlyle Group, one of the world’s largest and most successful investment firms. The company's executive leadership team has extensive diagnostic experience and a strong heritage of driving market change and innovation. Ortho is a strong brand with solid positions in attractive, growing segments and regions.\r\r\r\r\r\r\r\r\r\r\r\r\r\rThe Career Potential\r\r\r\r\r\r\r\r\r\rOrtho 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.\r\r\r\r\r\r\r\r\r\r\r\r\r\rThe Opportunity\r\r\r\r\r\r\r\r\r\rAs the company continues to grow, we are seeking a Quality Analyst I, located in Rochester, NY.The Quality Analyst in the Fluids Release Laboratory assures the outgoing quality of the Calibrators, Controls and reagents by executing analytical testing , providing accurate release data, and confirms product performance meets specifications and claims.\r\r\r\r\r\r\r\r\r\r\r\r\r\rThe Responsibilities\r\r\r\r\r\r\r\r\r\rAssures 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 VITROS analyzers and other analytical equipment such as pH meter, viscometer, Conductivity meter, UV-VIS spectrophotometry, Flame photometer, Chloridometer, and CO2 Meter in compliance with procedures.Maintain equipment, reagents, and supplies.  Will require limited work in a freezer.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 solutionsPerform raw material, intermediates and final product testingCalibrate, troubleshoot and maintain laboratory instrumentation and equipmentGood written and verbal skills are required to draft and review standard operating proceduresParticipate in laboratory investigations, validations and verificationsProvide analytical and manual dexterity to deliver accurate and precise results from complex analytical methods.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.\r\r\r\r\r\r\r\r\r\r\r\r\r\rThe Individual\r\r\r\r\r\r\r\r\r\rAn Associates or Bachelor’s degree in Medical Technology, Chemistry, Biochemistry, and/or related discipline is required.Experience in a highly regulated manufacturing environment (Diagnostics, Medical Device, Pharmaceutical, or Consumer) is preferred.Prefer a minimum 2 years of laboratory experience.Knowledge of QA and QC principles and tools required.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 GMP is required and familiarity with quality audits 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. Visa sponsorship is not available for this position.#CB##LI-POST\r\r\r\r\r\r\r\r\r\r\r\r\r\rEqual Opportunity\r\r\r\r\r\r\r\r\r\rOrtho 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 PosterPay Transparency Notice\r\r\r\r\r\r\r\r\r\r\r\r\r\rPrivacy Statement\r\r\r\r\r\r\r\r\r\rYour privacy is important to us.  By continuing to use our site to apply to this position, you agree to our Candidate Notice, which outlines our privacy policies on information collected during the hiring process.

Company info

Ortho-Clinical Diagnostics, Inc.
Website : http://www.orthoclinical.com/en-us

Company Profile
Ortho Clinical Diagnostics serves the transfusion medicine community and laboratories around the world. We're the leading provider of total solutions for screening, diagnosing, monitoring and confirming diseases early before they put lives at risk. Our single focus is to help hospitals, laboratories and blood centers worldwide deliver results that help patients experience a better quality of life.

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