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 we continue to grow, we are seeking a Quality Analyst II. The Quality Analyst II is responsible to provide product quality support to Ortho Clinical Diagnostics (Raritan NJ) in support of product manufacture, validation, product-related projects and investigations. Ensure quality systems activities and site projects are executed in compliance with Ortho Clinical Diagnostics policies and procedures, and applicable regulations and standards (e.g. QSR, CMDR and other international regulations per product, ISO 13485 standard, 21 CFR 200's).

• Responsible for communicating and elevating critical business related issues as well as opportunities to management.

• Reviews and approves drug and device history records to include:

  • Verification of technical accuracy.

  • Compliance to Specifications/Requirements, Quality System Regulations and GMPs

  • Compliance with Ortho Clinical Diagnostics processes and procedures.

• Assures product meets all the criteria prior release to CBER/TUV and/or to customers.

• Recommends final dispositions of product and performs product release in inventory system.

• Identifies and follows up with Operations, Quality Engineering and QA on product quality/batch release discrepancies. Determines and recommends corrective action required.

• Prepares and verifies accuracy of Certificates of Analysis and CBER protocols. Prepares and submits documents for TUV lot approval.

• Measures and analyzes quality and process metrics for trending and quality and productivity reviews. Reports unusual trends to department and Operations management. Identifies areas of improvements, proposes resolution to problems and participates/leads investigation/improvement projects. Participates and contributes in intradepartmental project teams. Attend daily planning meetings and provide release updates.

• Participates in training for team members or external associates (Manufacturing and QA). Reviews and revises master device history records, manufacturing batch records, standard operating procedures and process documents.

• Supports investigations for customer complaints by performing batch review of impacted area.

• Provide internal and external audit support.

• Make decisions on the management of workflow to meet production deadlines.

• Perform other work-related duties as assigned.

• High School Diploma or GED equivalent required; Associates Degree or Bachelor's Degree in Medical Technology, Engineering or Science is preferred.

• 2+ years of overall experience in a quality environment is required.

Key Working Relationships

• Internal - Coordination with Manufacturing and Product Support during NC/RCI/CAPA processes and project execution. Partner with Laboratories during OOS and OOT investigations; coordinate with Planners in support of product release

EOE/AA Disability/Veteran