Staff Chemist-2

QuidelOrtho • Carlsbad, CA

12h • $89,009 - $115,712 • Onsite

About The Position

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.

Requirements

• 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.

Nice To Haves

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

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 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level