Advanced Research Associate - Quality Control Immunoassays

Role Summary

Advanced Research Associate - Quality Control Immunoassays. Performs immunoassay quality control testing to check quality performance of products, maintain accurate documentation of results, and maintain assay databases for immunoassay products including Quantikine, DuoSet, Luminex, IVD kits, and related product lines.

Responsibilities

• Perform ELISA assays according to procedures to check in-process and final product for quality performance.
• Reduce and evaluate data from assays; record data on proper documents.
• Assist in transfer of new products and 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.
• Maintain and enter assay data into assay databases.
• Review assay information and exercise judgement to determine appropriate action within defined procedures and practices.
• Assist in validations by organizing materials, performing assays, and keeping data records.
• Perform troubleshooting activities under supervision.
• Assist in implementing change control. Write and/or revise standard operating procedures as needed.
• Train other team members as needed.
• Compile reports and present data with proposed action plan under supervision.
• Follow company policies and safety guidelines as outlined in manuals; perform additional duties as assigned.

Qualifications

• Education: Bachelor of Science in Biology, Chemistry, Biochemistry, or related field with 2+ years of related experience, or Master’s degree with up to 2 years related experience.
• Experience: Experience in clinical laboratory or quality control systems with knowledge of good manufacturing practices preferred.

Knowledge, Skills, And Abilities

• Working knowledge of Microsoft Word and Excel, including data entry.
• Ability to 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 accuracy.
• Ability to work independently and in a team, collaborating across groups.
• Technical knowledge of lab techniques, equipment, software, immunoassays, and safety practices.
• Flexibility to work alternate or additional hours as needed.