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 RoleAs we continue to grow as QuidelOrtho, we are seeking a Senior Process Group Chemist. The Senior Process Group Chemist assists in coordinating the planning and scheduling efforts of the production schedule in support of the specific product line(s). This involves ensuring the timely manufacture of the specific product line(s) as per the production schedule and coordinating the resolution of technical or other issues in a timely fashion. The position maintains all Statistical Process Control (SPC) and other product specific data, investigates the root cause of any notable data points and ensures compliance to all Quality standards, policies, and procedures. The Senior Process Group Chemist trains and evaluates employees on product-specific processes and procedures and is responsible for financial accountability to manufacturing standards, yields, and scrap. This role will be located in Carlsbad, CA.
The ResponsibilitiesManufactures (i.e. Formulates bulks, and Quality Controls) products (i.e. Lateral flow devices, controls/calibrators and microtiter systems) while adhering to regulatory requirements and business polices /procedures and schedules
Provides training to chemistry staff on Manufacturing Instructions and Standard Operating Procedures (SOP)
Coordinates the activities of the Chemists working on product-specific work orders
Displays leadership by assessing issues affecting departmental performance, Quality standards, and product quality, communicates to management then initiates appropriate corrective action
Reviews completed Device History Records and performs financial reviews of work orders then initiates appropriate corrective action through Engineering Change Orders (ECO)
Ensures product is completed on schedule and may participate in development of the weekly production schedule
Write /revises documentation as required to improve product-specific processes then implements corrective actions as necessary to address documentation and process issues
Assists with the review and implementation of ECO's
Required Skills:
Technical expertise in the specific product
Competent in all manufacturing procedures related to the specific product
Basic algebraic, statistical and mathematical skills
General computer knowledge and experience with EXCEL or equivalent programs
Specific computer knowledge related to the ERP program
Proficient in data analysis, data summary, and presentation
Good organizational skills
Laboratory skills, such as protein purification, antibody conjugation, solution preparation, ELISA experience, assay development skills, knowledge of experimental design etc.
Good verbal, written and interpersonal communication skills
Knowledge of QSR's and ISO 13485
Preferred Skills:
B.S./B.A. Life/Applied Sciences or equivalent
Minimum 5 years of related work experience in a GMP environment
Internal Partners:
Process Engineering, Production, Planning, R&D, Quality
The Work EnvironmentThe work environment characteristics are representative of a laboratory environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues and samples. Flexible work hours to meet project deadlines.
Position requires ability to lift up to 20 lbs. on a regular basis. Up to 75% of time at lab bench or desk, walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Must have the ability to operate lab equipment. Position requires use of Personal Protective Equipment as posted.
Salary TransparencyThe 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 $64,300 to $118,000. 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.
EEOQuidelOrtho 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
#LI-HF1