Quality Analyst II-MicroWell Release Lab

As we continue to grow as one QuidelOrtho, continues we are seeking a Release Lab Analyst II to work in our new manufacturing factory at the Canal Ponds campus. The Quality Analyst II in the Release Laboratory executes complex analytical and quality data analysis of VITROS Calibrators, Controls, Reagents and other product fluids to support the formulation, release process, stability testing to evaluate the accuracy of the VITROS products. This testing uses a variety of instrumentation including, but not limited to, VITROS 3600, 5600 and Eci Chemistry Systems and other analytical equipment as needed.

In addition, the Quality Analyst II will lead junior laboratory staff by scheduling the lab testing to support the production schedule. Will also assist in laboratory investigations and assures the product performance meets specification and claims. This position requires creating and maintaining assay test templates and specifications in the data analysis software, writing quality records to support product test failures, evaluation of quality control, and troubleshooting. The daily work is expected to follow established methods and procedures so it can be performed efficiently and in a timely manner.

This position will initially be supporting MicroWell product line and may also include performing these job duties in other release laboratories within Ortho Clinical Diagnostics Building 313 and 642.

This position is in Rochester, NY.

• 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 complex quality data analysis on all types of release tests. This includes the use of validated spreadsheets and the laboratory data analysis software. Create Quality records for test failures and escalates to management.

• Maintain Quality documents when product specifications change due to new lots of internal test fluids or a result of a Non-Conformance investigation.

• Perform reagent, calibrator, performance verifier, fluid intermediates and final product testing. Organize and ensure completion of Release Laboratory testing within established standard operating procedures and frequently assist team members to accomplish product release tests to meet production timelines.

• Participate and/or lead Release Laboratory investigations. The individual will contribute to the documentation of any quality records resulting from investigations or product releases.

• Review data of internal controls and other release fluid crossover tests for accuracy and completeness and serve to provide the peer review of other staff member's data.

• Maintain lab supply inventory for testing of VITROS Products and manages equipment maintenance/calibration records schedule.

• Participate in Laboratory Validations of new assays and is responsible for the assay configuration in the laboratory data analysis software.

• Bachelor's degree in scientific or related field. Equivalent combination of education and experience may be considered.

• 2 years or more of work experience in Biology, Microbiology, Quality, Regulatory, or Compliance in a highly regulated manufacturing environment (Diagnostics, Medical Device, Pharmaceutical or Consumer) is preferred.

• Problem-solving skills and attention to detail are required.

• Ability to work independently and as part of a team.

• Strong problem-solving skills.

• Strong attention to detail.

• Strong written and verbal communication skills.

• Ability to work independently and as part of a team.

• Ability to work overtime and occasional weekends or alternate shifts as needed.

Internal Partners: Management, Production Engineers, Maintenance Operators, Quality Analysts/Scientists, Quality Engineers, Products and logistics team, Product Support Team, R&D scientists

External partners: Outside Vendors and Instrument Service Personnel

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $58,000.00 - $99,000.00 USD annually. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

QuidelOrtho 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. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their 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 .

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