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 as QuidelOrtho, we are seeking a Scientist I – Chemistry. This position is responsible for routine and non-routine chemistry testing according to established procedures or approved protocols. This position is located in Raritan, NJ.
Work Schedule: Monday to Friday, 7:00 AM to 3:30 PM, with adjustments as needed based on the testing schedule.
The Responsibilities
- Perform raw material, intermediate, final product testing. Support all non-routine testing such as validations and any other required studies.
- Document results clearly and accurately. Interpret results by comparing against appropriate specifications and/or requirements.
- Knowledge on analytical chemistry equipment, principles, theories, practices and methodology to align with current procedures and Pharmacopoeias.
- Calibrate and maintain laboratory equipment and maintain supplies inventory levels.
- Provides support during Compliance and Regulatory inspections. Support of validation activities and process improvements.
- Maintains current knowledge of quality guidelines and regulations (cGMP).
- Perform peer data reviews and prepares documentation of product release ensuring on time completion to meet production requirements. Monitor and evaluate product testing results identifying and responding to adverse quality trends.
- Participate in laboratory investigations, technology transfer, validations and R&D projects.
- Technical writing skills to successfully resolve laboratory investigations, product nonconformances, Corrective/Preventive Actions and/or to improve product design.
- Develop, write, update, review, approve and implement test methods, SOPs, protocols, reports and specifications as required. Training self and others on new/revised SOPs QATs SPCs etc. Coordinate training for new employees and contractors.
- Perform other work-related duties as assigned.
The Individual
Required
- Bachelor’s degree in chemistry, Biochemistry, Chemical Engineering, or related field is required.
- Minimum 0-2 years of analytical chemistry laboratory experience in a regulated environment is required.
- Experience with analytical chemistry equipment.
- Knowledge of quality guidelines, standards, and regulations (cGMP).
- Good verbal and written communication skills required.
- Experience working in an FDA regulated environment preferred.
- Knowledge of technical writing techniques to perform laboratory investigation.
Preferred
- MS Office, Excel, Empower or Chem Station
Key Working Relationships
- Internal Partners: Manufacturing/Operations, Materials and Production Planning, Product Quality, Quality Engineering, Product Support.
- External Partners: Vendors/Suppliers
The Work 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.
Physical Demands
- Some lifting up to 30 lbs.
- Manual dexterity for handling instruments and repetitive motion
- Standing for extended periods
- 75% in the lab, requiring walking, standing, and sitting for long periods
- 25% in meetings or on the phone
- Wearing appropriate PPE in the lab
- Close and distance vision, ability to adjust focus
- Ability to operate lab equipment
- Adherence to personal protective equipment guidelines
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 64,000 annual. 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 recruiting@quidelortho.com.
