Quality Analyst – MicroWell Release Lab

Overview

The Opportunity Quidel Ortho 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 Opportunity We are seeking a Quality Analyst I to execute complex analytical testing of VITROS Calibrators, Control and other product fluids to support the formulation, release process, stability testing and accuracy of the VITROS products. This testing uses a variety of instrumentation including, but not limited to, VITROS 5,1 Chemistry System, pH meter, Chloride meter, conductivity meter and manual spectrophotometers.

Will maintain VITROS instrumentation, calibrates, run quality control and analyze requested samples. 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. This position is located in Rochester, NY

Work Schedule:

A shift flexible based on the business needs typically 7:30 am to 4 pm. May require over-time and occasional C or B shifts based on production needs and schedule.

• Complete release and in process tests supporting Vitros products by executing analytical testing on multiple types of equipment in compliance with all procedures; and provide analytical and manual dexterity to deliver accurate and precise results.
• Perform reagent, calibrator, performance verifier, fluid intermediates and final product testing.
• Organize and ensure completion of Fluids Release Laboratory testing within established standard operating procedures and will frequently assists team members to accomplish product release tests to meet production timelines.
• Participate and/or assist in Fluids Laboratory investigations, may partner with Product Support to resolve issues and complete test results in a timely manner. May also contribute to the documentation of any quality records resulting from investigations or product releases.
• Complete analysis of data using spreadsheets or LIMS to report testing results. Complete crossover testing for some internal controls. Review data for accuracy and completeness and serve to provide the peer review of other staff member’s data.
• Maintain equipment, reagents and supplies required for testing VITROS and products.
• Performs additional work related duties as assigned.

Required:

• Associate’s Degree in scientific or related field with a minimum of 2 years of laboratory experience or equivalent combination of education and experience.
• Strong problem-solving skills
• Strong attention to detail.
• Ability to work independently and as part of a team.

Preferred:

• Experience in a highly regulated manufacturing environment (Diagnostics, Medical Device, Pharmaceutical, or Consumer) is preferred.

• Internal Customers:
  Management, Production Engineers, Maintenance Operators, Quality Analysts/Scientists, and Quality Engineers, Products and logistics team, Product Support Team
• External Customers:
  Outside Vendors and Instrument Service Personnel

The work environment characteristics are representative of both an office and laboratory environment and include handling of viral and bacterial hazards as well as infectious or potentially infectious bodily fluids, tissues, and samples. Position requires ability to lift to 20 lbs. on a regular basis. Walking, standing, and sitting for long periods of time (up to 75% of the day) are routine to accomplish tasks in this…