Quality Analyst 2

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, located in Rochester, NY. The Quality Analyst assures the outgoing quality of the Calibrators, Controls and reagents by reviewing analytical release data, provides input into the troubleshooting investigations and confirms product performance meets specifications and claims.

The Responsibilities

  • The Quality Analyst will provide leadership and/or technical support to Product Support, PPL, Quality Regulatory and Compliance, Validation Engineers and Operations Lab staff.

  • Assures compliance to inspection readiness programs within the organization.

  • Responsible for both data-based and risk-assessment-based decisions for setting accuracy of uTIP assays and Calibrator and Control fluids.

  • Utilizes industry and process excellence standards (PEx) in daily quality operations, when addressing complex production issues.

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

  • Monitors product performance (Precision, Accuracy, Linearity) and is responsible for initially addressing or if needed, escalating product and process concerns.

  • Leads and supports teams to investigate quality issues (failure investigations) that resolve complaints and nonconforming products.

  • Supports development and investigative projects.

  • Works independently to issue and investigate quality, and compliance related non-conformances using a systematic approach to problem solving, conducting risk analyses and ensuring appropriate corrective and preventative actions to drive improvements.

The Individual

  • An Associates or Bachelor's degree in Medical Technology, Chemistry, Biochemistry, and/or related discipline is required.

  • A minimum of 2 years of experience in a highly regulated manufacturing environment (Diagnostics, Medical Device, Pharmaceutical, or Consumer) is required.

  • Ability to problem solve and make risk based decisions on VITROS product performance that will maintain calibration traceability and product claims without adversely impacting clinical decisions.

  • Knowledge of current good lab practices, applicable GMP is required and familiarity with quality audits is recommended.

  • The ability to think independently while effectively prioritizing and managing multiple project workloads is required.

  • Excellent written and oral communication skills for presenting technical reports and defending release decisions to cross-functional groups is needed.

  • The ability to participate in complex, technical and cross-functional projects is required.

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

Preferred:

  • Experience with Six Sigma/Process Excellence tools, training and/or certification is preferred.

  • Experience in a hospital laboratory-like environment is beneficial but not required.

  • Ability to understand the implications of making VITROS performance decisions and their effect on the health will be needed.

  • Experience with VITROS Value Assignment and uTIP data analysis in QDIS-R LIMS is preferred.

  • Ability to interface with multiple applications (i.e. QERTS (nonconformance) and OTIS (change control) is preferred.

  • A working knowledge of the testing, data analysis and evaluation of value assignments for uTIP assays and calibrator control fluids allows for final data review, disposition and release to the ADD.

  • The ability to manage quality documentation utilizing QERTS records to initiate NCs, resolve CAPAs, contribute to DRAs and aid in the closure of quality records is required.

  • Proficiency with the OTIS change control process allows planning, execution and completion of a project to expedite change and minimize customer disruption.

  • Work visa sponsorship is not available for this position

The Opportunity

Ortho Clinical Diagnostics is recruiting for a Quality Analyst, located in Rochester, NY. The Quality Analyst assures the outgoing quality of the Calibrators, Controls and reagents by reviewing analytical release data, provides input into the troubleshooting investigations and confirms product performance meets specifications and claims.

The Responsibilities

  • The Quality Analyst will provide leadership and/or technical support to Product Support, PPL, Quality Regulatory and Compliance, Validation Engineers and Operations Lab staff.

  • Assures compliance to inspection readiness programs within the organization.

  • Responsible for both data-based and risk-assessment-based decisions for setting accuracy of uTIP assays and Calibrator and Control fluids.

  • Utilizes industry and process excellence standards (PEx) in daily quality operations, when addressing complex production issues.

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

  • Monitors product performance (Precision, Accuracy, Linearity) and is responsible for initially addressing or if needed, escalating product and process concerns.

  • Leads and supports teams to investigate quality issues (failure investigations) that resolve complaints and nonconforming products.

  • Supports development and investigative projects.

  • Works independently to issue and investigate quality, and compliance related non-conformances using a systematic approach to problem solving, conducting risk analyses and ensuring appropriate corrective and preventative actions to drive improvements.

The Individual

  • An Associates or Bachelor's degree in Medical Technology, Chemistry, Biochemistry, and/or related discipline is required.

  • A minimum of 2 years of experience in a highly regulated manufacturing environment (Diagnostics, Medical Device, Pharmaceutical, or Consumer) is required.

  • Ability to problem solve and make risk based decisions on VITROS product performance that will maintain calibration traceability and product claims without adversely impacting clinical decisions.

  • Knowledge of current good lab practices, applicable GMP is required and familiarity with quality audits is recommended.

  • The ability to think independently while effectively prioritizing and managing multiple project workloads is required.

  • Excellent written and oral communication skills for presenting technical reports and defending release decisions to cross-functional groups is needed.

  • The ability to participate in complex, technical and cross-functional projects is required.

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

Preferred:

  • Experience with Six Sigma/Process Excellence tools, training and/or certification is preferred.

  • Experience in a hospital laboratory-like environment is beneficial but not required.

  • Ability to understand the implications of making VITROS performance decisions and their effect on the health will be needed.

  • Experience with VITROS Value Assignment and uTIP data analysis in QDIS-R LIMS is preferred.

  • Ability to interface with multiple applications (i.e. QERTS (nonconformance) and OTIS (change control) is preferred.

  • A working knowledge of the testing, data analysis and evaluation of value assignments for uTIP assays and calibrator control fluids allows for final data review, disposition and release to the ADD.

  • The ability to manage quality documentation utilizing QERTS records to initiate NCs, resolve CAPAs, contribute to DRAs and aid in the closure of quality records is required.

  • Proficiency with the OTIS change control process allows planning, execution and completion of a project to expedite change and minimize customer disruption.

  • Work visa sponsorship is not available for this position

#CB#

#LI-POST

#LI-SC1

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

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Quality Analyst 2

Ortho-Clinical Diagnostics