Location: Rochester,NY, USA
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 we are seeking a Scientist III for our Fluids Manufacturing facility, who possesses strong analytical skills, experience in product testing, quality control, and the ability to translate complex data into actionable recommendations. This position will be responsible for providing technical advice on product validations, handling product nonconformance investigations by defining necessary performance testing, and potentially conducting these tests to ensure product quality and supply continuity. Furthermore, this role involves supporting product and process validations for corrective actions material obsolescence. Key responsibilities include leading or assisting in projects aimed at enhancing product performance, operational efficiency, and customer satisfaction. The Scientist III will offer data-driven insights for product risk assessments related to validation and nonconformance issues.
This position is located in Rochester, NY.
The Responsibilities
This role requires both independent work and teamwork, with a focus on quality documentation, data analysis and sound technical conclusions, and compliance in a regulated manufacturing environment.
* Conduct root-cause investigations of production failures and atypical results.
* Evaluates product risk and recommend product dispositions and corrective actions.
* Document conclusions within QuidelOrtho's quality system and present findings for review at Materials Review Board (MRB) in a small team format when applicable.
* Define product performance test plans and develop test designs to evaluate critical to quality product characteristics in a timely manner to maintain the continuity of supply.
* Support product/process investigations, material obsolescence projects and corrective actions or product improvements. Projects include managing and documenting changes in QuidelOrtho's quality system.
* Review and analyze data to draw conclusions and make recommendations for product disposition and to evaluate product changes when applicable.
* Lead moderate to large complexity projects and product validations.
* Author validation reports including testing protocols, data analysis and implementation activities.
* Maintain knowledge of cGMP requirements and ensure compliance
* Follow safety protocols and wear appropriate PPE in laboratory and manufacturing environments
* Assist with internal and external audits
* Adhere to quality, regulatory, and safety guidelines
The Requirements
Required:
* Minimum BS degree in scientific field (Biology, Chemistry, or Engineering preferred) with minimum 7-10 years relevant experience in biological fluids manufacturing or equivalent for Scientist III.
* Experience conducting root cause investigations and familiarity with Process Excellence tools or equivalent methodologies.
* Ability to work in a manufacturing environment and handle urgent issues.
* Strong analytical and documentation skills including report writing, statistical knowledge.
Preferred:
* Masters degree.
* Familiarity with VITROS MicroSlide and/or MicroTip products and with VITROS analyzers.
* Proficiency with Minitab (or equivalent) statistical software.
The Key Working Relationships
Internal Partners: Management, Production Engineers, and Quality Engineers
External Partners: Material Suppliers
The Work Environment
The work environment characteristics are representative of a manufacturing, laboratory and office environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Majority of the time is office based with some time in laboratory and manufacturing. Flexible work hours to meet project deadlines.
Salary Transparency
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 $60,000 to $110,000 and is bonus eligible or eligible for incentive compensation. 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.
Equal Opportunity
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 the 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 ...@quidelortho.com.
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