Advanced Research Associate - ProteinSimple QC

$49,700.00 - $81,650.00

Position Summary: 

Perform routine quality control testing to determine lot status and product release for the ProteinSimple capillary electrophoresis basis systems, including iCE and SimpleWestern.  This position is responsible for planning, executing, and managing activities in the ProteinSimple liquid and lyophilized reagent QC process to ensure that all applicable objectives are met, and the product functions as expected. To be successful in this role candidate needs to be skilled in analytical techniques for analysis of biological assays. This position interfaces with Manufacturing, Process Engineering, Product Support, Assay Development and Quality Assurance. 

Key Responsibilities: 

• Compile, document, interpret and manage data from ProteinSimple capillary electrophoresis systems, including iCE and Simple Western platforms, to evaluate the quality of in-process materials and finished goods to either confirm compliance with established quality standards or identify deviations. This includes functional, assay performance, precision, and accuracy testing. Data management comprises analysis and disposition of data produced and curation of that data into established systems. 

• Ensure that the final product satisfies the product requirements and meet end-user expectations 

• Revise SOPs of moderate complexity 

• Initiate and support deviation and out-of-specification investigations 

• Provide recommendations for corrective actions for low complexity problems and processes 

• Spot areas for improvement to enhance the QC testing and process efficiency 

• Maintain clear and accurate records 

• Attend cross-functional team meeting and present data summaries 

• Perform lab work when needed, including preparation of controls and reagents, and performing instrument runs 

• Support projects and new product launch activities of moderate scope that require data review, and contribute to basic project deliverables 

• May participate in method validations, establishing specifications and writing standard operating procedures 

• Train team members within the department 

• Support other QC operations, as needed 

Education and Experience: 

• Bachelor’s degree in Biology, Chemistry, Engineering or similar science degree with 2+ years’ experience. 

• Master’s degree in Biology, Chemistry, Engineering, or similar relevant experience 

Knowledge, Skills and Abilities: 

• Knowledge of basic laboratory equipment and skills such as micropipetting, electrophoresis, isoelectric focusing, western blotting, QC functions, test procedures. 

• Ability to apply understanding of electrophoresis techniques and data analysis to technical troubleshooting or project execution 

• Outstanding analytical skills, particularly focused in algebraic equations for solving calculations related to evaluating chromatograms 

• Ability to independently troubleshoot abnormal test results and determine next steps of moderate complexity 

• Work fully independently on routine tasks and other tasks beyond daily expectations 

• Flexibility to effectively prioritize own work and manage the work of multiple tasks 

• Experience working with and evaluating data with Excel and proficient in all Microsoft Windows functions, as well as JMP and GraphPad Prism 

• Ability to evaluate moderate volumes of data in a short timeframe 

• Strong understanding of quality system regulations and standards 

• Experience working within an ISO compliant, or other regulated environment. 

• Experience developing, reviewing, deploying Standard Work (WI’s, MI’s, SOPs) 

• Experience presenting assay data and interpretations 

• Demonstrated ability to deliver quality work, with high work accuracy. 

• Demonstrated ability to meet project timelines and collaborate with internal team 

• Organized with exquisite attention to detail