Senior Research Associate - QC Immunoassays

Role Summary

Senior Research Associate - QC Immunoassays: Responsible for performing immunoassay quality control testing, maintaining documentation and assay databases, with a focus on large-scale data management for immunoassays (notably the Luminex product line).

Responsibilities

• Perform immunoassays according to procedures to evaluate in-process and final products for quality performance.
• Reduce and evaluate data from assays; record data on proper documents. Maintain and enter data into assay databases. Create large-scale databases for data trending and historical analysis.
• Review assay information for in-process product approval and exercise judgment to determine appropriate action.
• Have strong immunoassay knowledge and troubleshooting skills to identify root causes of issues.
• Find process improvements to improve product quality and/or process efficiency with a focus on data analysis efficiency for the Luminex product line.
• Assist in transfer of new products & technologies from development, including attending project meetings, performing assays, and evaluating results.
• Calibrate equipment according to schedule and keep updated records of calibrations.
• Formulate reagents needed for testing according to existing SOP documents.
• Write test method validation plans and reports; assist in validations by organizing materials, performing assays, and keeping data records.
• Write and revise standard operating procedures, including instrument maintenance, qualification and calibration.
• Collaborate with Development, Operations, Process Engineering, and QA to ensure product performance; perform troubleshooting testing and assist in change control.
• Be a leader in the lab, developing other team members.
• Compile reports and present data with proposed action plans.
• Follow company policies and safety guidelines; perform additional duties as assigned.

Qualifications

• Education: Bachelor of Science in Biology, Chemistry, Biochemistry, or related field with 5+ years of related experience, or Master’s degree with 2+ years related experience.
• Experience in clinical laboratory or quality control systems; good manufacturing practices knowledge preferred.
• Experience with macros and database management; knowledge of Python and VBA to analyze large data sets desirable.

Skills

• Working knowledge of Microsoft Word and Excel.
• Ability to work in a fast-paced environment, follow SOPs, plan, multi-task, and meet deadlines.
• Data analysis skills for effective decision making.
• Strong verbal and written communication across groups/sites.
• Strong organizational skills, attention to detail, accuracy.
• Ability to work independently and in a team; technical knowledge of lab techniques, equipment, software, immunoassays, and safety practices.
• Flexibility to work alternate or additional hours as needed.

Education

• As listed in Qualifications.

Additional Requirements

• None beyond listed qualifications.