Staff Process Group Chemist

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.

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.

• 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 documents including SOP's, MRP's, spec's and QTP's

• Independently identifies opportunities for process improvements that result in significant savings of manufacturing costs. Develop and implements robust solutions in a timely and cost-effective manner.

• Collaborates with the management team to establish objectives, milestones, and timelines for completion. Reports progress and results to Management on regular basis.

• Optimizes the performance of the manufacturing process by identifying areas to implement new processes or refine existing ones; implements additional process controls into current production processes to ensure the highest quality can be achieved.

• Scaling up production processes to improve yields and reduce costs.

• May investigate alternate materials or equipment to improve the overall product performance or implement new equipment to reduce labor.

• Influences best practices and SOP's. proposes create solutions for ongoing production issues, process improvements and identifies opportunities to streamline existing processes to improve efficiency.

• Executes more complex and technically challenging lab processes. Identifies procedural process gaps and implements corrective actions to remediate.

• Drafts validation protocols, reports and technical memos for complaints. Provides timely updates and reports status for active projects to direct Management.

• Provides technical expertise and mentoring to junior level production chemists.

• Coordinates and champion new product/process transfers and validations. Ensure required documentation is complete. Collaborate with R&D/Process Development to establish transfer timelines consistent with targeted introduction date

• Performs other duties & projects as assigned

Required:

• B.S./B.A. Life/Applied Sciences, similar field or equivalent experience

• Minimum 10 years of related work experience in a GMP environment

• Highly specialized skills in data analysis, computer programing to use for statistical analysis

• Excellent troubleshooting skills

• Experience in and highly familiar with various chemistry production procedures and policies

• Excellent knowledge of a variety of lab equipment and their operation is required

• Strong algebraic, statistical and mathematical skills

• Strong problem-solving and troubleshooting 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

• Strong 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

• This position is not currently eligible for visa sponsorship.

Preferred:

• Master's degree

• Previous training and experience in the operation of lab equipment and use of lab chemicals and tools

• Knowledge of QSR's and ISO 13485

Inventory Control, Process Engineering, Production, Planning, R&D, Technical Support & Quality Assurance Department

The 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.

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 $89,008.92 - $115,711.59 and is bonus eligible. 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.

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.

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