Scientist II

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

The Scientist II is a full-time position in Clinical Chemistry Operations Product Support and will be responsible for working both independently and as a team member to contribute to and complete specific product investigations, product dispositions and obsolescence projects. The work will directly support supply continuity and validation activities (raw material/supplier changes, process improvements, supplier-initiated validations). This role primarily supports the VITROS MicroTip product line. This position is located in Rochester, NY.

The Responsibilities

• Responsible for supporting MicroTip product line by executing, evaluating and documenting product disposition, validation and other investigative VITROS testing.
• This role includes approximately 50%-70% VITROS MicroTip laboratory work, with additional responsibilities including data analysis, writing and documentation. The mix of laboratory work and analysis/documentation and project work will depend on current business priorities and current projects.
• The testing on VITROS analyzers and maintaining laboratory equipment and reagent and supplies inventory. Laboratory portion of the work includes obtaining necessary materials, maintaining inventory, analyzer maintenance, test preparation, testing samples on VITROS analyzers, performing VITROS analyzer maintenance, and troubleshooting in the laboratory (BL2 lab) and occasionally shipping materials to suppliers.
• Responsible for accurate and clear testing documentation and data analysis. Create and edit test design documents, complete data analysis for testing and summarize results for validation, product disposition records.
• Conduct product disposition evaluations, with guidance, within QERTS and document with supporting rationale, which may include summarizing results and presenting for review at Materials Review Board (MRB).
• This role may also serve as technical contact for some MicroTip suppliers, coordinating review and approval of supplier data and changes, as necessary. This includes leading regularly conference calls and requires excellent communication and organizational skills.
• This role could lead project qualifications and validations of a moderate complexity, with guidance. Prepare reports, including protocols, testing analysis, and summary reports.
• Opportunity to initiate change requests and associated change documents for project validations and product improvement studies. Create, revise, and approve controlled documents as required.
• Provide testing and support for on-going Process Improvement Projects, including but not limited to, supplier obsolescence, supplier changes to raw materials, and changes to internal testing procedure/processes.
• Maintain working knowledge of cGMP requirements to ensure adherence to compliance policies and regulations. Wear the appropriate PPE when working in the laboratory and manufacturing environments.
• Assist in internal and external audit preparation and participation, as needed.

The Individual

• Bachelor's Degree in Medical Technology, Science, or Engineering, or equivalent.
• Minimum 3 years experience associated within laboratory within a FDA regulated industry.
• Experience with VITROS analyzers preferred. Experience with MicroTip products a plus.
• Experience with LIMS data analysis highly preferred.
• Experience in change control documentation systems (Windchill) a plus.
• Strong written and verbal communication skills
• Excellent attention to detail.
• Ability to demonstrate flexibility and adaptability.
• Organization skills important to work on several projects in parallel.
• Ability to work both independently and within a team environment.

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EOE/AA Disability/Veteran