Pay Range:

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

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

• Provide recommendations for corrective actions for problems and processes of all complexities

• 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 all scopes, some of which require data review of unclear factors, and may be responsible for basic project deliverables

• May be responsible for new method validations, establishing specifications and writing standard operating procedures

• May train and give scientific guidance to others as needed

• Support other QC operations, as needed

Education and Experience:

• Bachelor’s degree in Biology, Chemistry, Engineering or similar science degree with 5+ years’ experience.

• Master’s degree in Biology, Chemistry, Engineering,  or similar relevant experience, with 3+ years’ experience.

Knowledge, Skills and Abilities:

• Knowledge of basic laboratory equipment and skills such as micropipetting, QC functions, test procedures and aseptic technique.

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

• Learns new techniques in a self-directed manner through research and other resources

• Outstanding analytical skills. R Analysis experience a plus.

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

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

• Super user level in Excel and proficient in all Microsoft Windows functions

• Ability to evaluate large 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)

• Strong presentation skills

• Experience with immunoassay methodology a plus

• 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