Quality Analyst I, Microbiology

The Opportunity

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

The Role

As we continue to grow as QuidelOrtho, we are seeking a Quality Analyst I to support our microbiology lab. This person will support the outgoing quality of the Calibrators, Controls and reagents by executing microbiological test procedures to confirm product performance meets specifications and claims. Also perform environmental monitoring testing, participate in Biocontrol GEMBA of the manufacturing control/critical areas and complete incident reports when applicable. The individual will also complete laboratory investigations for quality control issues as they arise and when appropriate initiate Non conformances.

 The position also maintains supplies/inventory/orders, ATCC library for QC of media, maintenance of equipment/ control and critical laboratory rooms. This individual will organize the logistics of the testing using the tools available for testing and transfers.

In addition, the Quality Analyst I works under the guidance of senior laboratory staff and management to resolve routine to complex analytical quality issues, assist in laboratory investigations and assures the product performance meets specification and claims.   Position requires creating test reports, analysis of technical data, evaluation of quality control, and instrument troubleshooting.  Work is scheduled, supervised, and follows established methods and procedures. Business decisions and product performance assessments are dependent upon the procedural attention to detail and technical ability of this individual.

This position is in Rochester, NY. This position will be working on B-Shift (3pm -11pm) but may require over-time and occasional A or C shifts based on production needs and schedule.

The Responsibilities

• Planning and organization of daily workload.  Works independently using specific technique to complete microbiological product release tests by performing testing on products, raw materials, water and environmental monitoring. Prepares product samples for multiple groups testing needs aseptically.

• Maintain equipment, reagents, room and supplies on the appropriate frequency.

• Assures compliance to inspection readiness programs within the organization and this individual will be responsible adhere to all quality, GLP, GMP and regulatory compliance policies. Completes Laboratory Investigations, Non Conformance Records, or Quality Investigations in a timely manner.

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

• Assures compliance to inspection readiness programs within the organization.

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

• Provide analytical and manual dexterity to deliver acc