Advanced Research Associate - ProteinSimple QC

Pay Range: $49,700.00 - $81,650.00

Perform routine quality control testing to determine lot status and product release for the Protein Simple capillary electrophoresis basis systems, including iCE and Simple Western. This position is responsible for planning, executing, and managing activities in the Protein Simple 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.

• Compile, document, interpret and manage data from Protein Simple 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 meets 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 meetings 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.

• 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 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 techniques to technical troubleshooting or project execution.
• Outstanding analytical skills, particularly focused on 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 Graph Pad 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.
• May be on computer monitor and keyboard for long periods of time.

We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and d.

We invest in our employees’ financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and…