This position is an integral part of Genomic Health's Operation team, leading QC testing and method development of raw material and components manufactured in-house to support Clinical Laboratory testing and new product and process development. The Senior Quality Control Development Scientist will have primary responsibility of ensuring the consistent quality of reagents and consumables used by the Clinical Laboratory. He or she will supervise and perform high complexity laboratory testing and contribute to the creation and implementation of required test methods, stability data, associated study protocols, reports and standard operating procedures to ensure quality issues with reagent or consumable lots are discovered and addressed prior to their use in our Clinical Laboratory. He or she will partner with Biostatistics, Quality, Supply Chain, Engineering, and Clinical Laboratory personnel in investigation of reagent quality issues, help drive continual improvement in efficiency of QC workflows and the effectiveness of QC methods, and train manufacturing or laboratory staff in new processes. The Senior Quality Control Development Scientist is responsible for the supervision of QC Analysts in the Reagent Manufacturing and Quality Group.
The high complexity nature of the work demands in-depth understanding of reagent and consumable QC testing, analytical methods and technology, and regulatory requirements. The successful candidate should also demonstrate a high degree of leadership and commitment to employee development, relationship building, communication and technical knowledge, with good attention to detail, ability to multi-task and be flexible with tasks and schedules, and ability to work both independently and in a team environment.
- Supervise QC Analysts in the Reagent Manufacturing and Quality group with direct management responsibilities including hiring, goal setting, professional development, mentoring, & training.
- Ensure reagent and consumable QC testing is performed according to the laboratory's standard operating procedures and within anticipated turnaround time.
- Draft, review, and update reagent quality control procedures and document any planned or unplanned deviations.
- Responsible for the review and approval of test data for raw materials and reagents manufactured in-house.
- Participate in cross-functional team efforts to develop, validate, and implement quality control test methods for new reagents and plastic consumables to reduce variability of genomic assays used for commercial patient sample testing and in clinical development studies.
- Partner with Genomic Sciences, Biostatistics, and other functions in the development and use of appropriate test methods for characterizing the composition, functional performance, and stability of reagents and consumables required for the development and launch of new products.
- Draft and implement new procedures, documents, and forms associated with reagent quality testing.
- Collaborate closely with colleagues in Quality, Supply Chain Management, Biostatistics, Process Engineering, R&D, and other functions to address and prevent supplier quality issues.
- Collaborate with Biostatistics and Quality to trend QC testing data on key reagents and consumables over time to provide insight into supplier process capabilities and detect indications of special cause variation in incoming lots.
- Assist in investigation and resolution of reagent / consumable-related issues with our laboratory processes (e.g. investigating special cause variation, changes in failure or repeat rates, other unusual behavior of reagents, consumables, or data), including assessment of impact, root cause identification, and appropriate corrective and preventive action.
- Ensure consistent compliance with applicable federal, state, and local regulations and quality-related best practices in development, validation, use, and documentation of analytical and functional test methods for reagent lot qualification, stability studies, and related activities.
- Additional responsibilities as assigned.