Quality Control Scientist I

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 the company continues to grow as QuidelOrtho, we are seeking a QC Scientist I. The QC Scientist I will be responsible for testing stability and final product release of all OCD products. This person will assure compliance with company standards and applicable regulatory agencies. They will participate in failure investigations to help determine root cause, track and trend data, identify and suggest process improvements to improve business measures.

This position will be onsite full-time at our Raritan, NJ office.

The Responsibilities

• Organizes and performs product release, stability and raw material testing under direct supervision. Performs testing within established timelines and in accordance with current specifications.
• Documents results clearly and accurately. Interprets results by complying to appropriate specification requirements. Perform data trending of critical product, process information and release test results to be used in SPC/ trend analysis.
• Maintains sufficient inventories off reagents and supplies.
• Assures compliance to company procedures, GMP, FDA, Safety and ISO regulations in all functions.
• Participate in laboratory investigations, technology transfer, validation and R&D projects.
• Manual dexterity to handle instruments, complete repetitive motions, and stand for long periods of time is required.
• Provide support during regulatory inspections.
• Repot nonconformance findings to management.
• Preforms other job duties as requested.

The Individual

Required:

• A bachelor’s degree in medical technology, Biology, Chemistry or a related field of study.
• Minimum of 1-3 years’ experience with QC, GMP, and analytical procedures is required.
• Proficiency with the Microsoft Office suite of products (Excel, Word, PowerPoint, Outlook) 

Preferred:

• Bachelor’s degree in Medical Technologies

Key Working Relationships

• Internal Partners: Planning, Quality Engineering and Product Support.
• External Partners: customers and vendors.

The Working Environment

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time at desk, standing or sitting extended periods of time. 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. The salary range for this position is $ 57,000 - 98,000. 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 Employment 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 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 [email protected]