Staff Chemist-2

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

At QuidelOrtho, we’re advancing the power of diagnostics for a healthier future for all. Join our mission as our next Staff Process Group Chemist. Under minimal supervision, the Staff Process Group Chemist coordinates 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 Staff 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 carries out complex manufacturing processes and tasks involving a variety of laboratory methods, equipment and procedures/tasks according to established GMP, under the direction of management.

This position will be onsite in Carlsbad, CA.

The Responsibilities

• Manufactures (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)

• Plans, coordinates and directs 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

• Effectively communicates with all support groups (inventory, quality control, planning and management).

• Influences best practices and Standard Operating Procedures.

• Conducts the most complex and vital lab activities.

• Identifies and acts upon issues affecting departmental performance, Quality standards, and product quality.

• Assists with the transfers of new products to manufacturing including validation of equipment and/or processes.

• Drafts and revises