Senior Research Associate - Quality Control Immunoassays

Role Summary

This position is primarily responsible for performing immunoassay quality control testing to check for quality performance of product, maintain accurate documentation of results, and maintain assay databases. These immunoassay products include Quantikine, DuoSet, Luminex, IVD kits, Simple Plex, and related product lines. The role also focuses on managing large-scale databases for immunoassays, especially for the Luminex product line, and pursuing annual goals to facilitate innovation, efficiency, productivity, and team building across the QC Department and/or within the company.

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 judgement (within defined procedures and practices) to determine appropriate action.
• Have strong immunoassay knowledge and solid troubleshooting skills to independently identify root causes of issues.
• Find process improvements in daily routines 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 various departments, including Development, Operations, Process Engineering, and Quality Assurance (QA) to ensure the performance of products. Perform troubleshooting testing as required and assist in writing and implementing change control.
• Be a leader in the lab helping develop other team members.
• Be self-sufficient at compiling reports and presenting data with proposed action plan.
• Follow company policies and safety guidelines as outlined in relevant manuals.
• Perform additional duties as assigned.

Qualifications

• Required: Bachelor of Science degree in Biology, Chemistry, Biochemistry, or related field with 5+ years of related experience, or a Master’s degree with 2+ years related experience.
• Preferred: Experience in clinical laboratory or quality control systems with a thorough knowledge of good manufacturing practices.
• Preferred: Experience with creating and maintaining macros as well as database management. Experience with programs like Python and VBA to analyze large data sets.

Skills

• Working knowledge of Microsoft Word and Excel
• Ability to work in a fast-paced environment, follow written SOPs, plan, multi-task, and prioritize to meet deadlines
• Ability to analyze data to make effective decisions
• Strong verbal and written communication skills across groups and sites
• Strong organizational skills, attention to detail, and high level of accuracy
• Ability to work independently and in a team
• Solid technical knowledge of lab techniques, equipment, software, immunoassays, and safety practices
• Flexibility to work alternate or additional hours as needed

Education

• Bachelor of Science in Biology, Chemistry, Biochemistry, or related field (5+ years experience) or Master’s degree (2+ years experience)