Clinical Lab Associate, ELISA/Immunoassay Testing (Broomfield, CO)

Benefits

Qualifications

• •Hands-on lab experience with ELISA technique and pipetting skills
• •Comfort working in a regulated laboratory environment (CLIA, CAP, or equivalent)
• •Ability to work staggered/flexible schedules as the lab scales throughput
• •Ability to work on-site in Broomfield, CO full-time
• •𝗕𝗼𝗻𝘂𝘀 𝗣𝗼𝗶𝗻𝘁𝘀:
• •Experience operating Aligria 2 instruments
• •Bachelor's or Associate's degree in medical technology, clinical laboratory science, or a biological/chemical science
• •ASCP certification (MLS, MLT, or equivalent)
• •Experience with IFA or chemiluminescence immunoassay platforms
• •Prior exposure to autoimmune or IBD diagnostic testing
• •Familiarity with FDA 510(k) validation or CAP/API proficiency testing programs
• •Note: Lab experience is prioritized over degree level for these direct hire roles
• •9 more items(s)

Responsibilities

• •You'll run high-complexity immunoassay testing on validated instrumentation, contribute to a 180-assay validation effort, and work alongside a tight-knit team that's been together for years
• •You'll report to clinical laboratory leadership and join a bench team running daily diagnostic testing on serum samples using Aligria 2 immunoassay instruments
• •The lab currently operates on one shift and is moving toward staggered schedules to maximize throughput as the FDA validation program accelerates
• •This is a hands-on, documentation-driven role with direct line of sight from your daily testing work to a major regulatory milestone
• •The validation work runs in parallel with a sister team in Germany, giving you international exposure without requiring any travel
• •𝗪𝗛𝗔𝗧 𝗬𝗢𝗨'𝗟𝗟 𝗗𝗢
• •Run three instrument runs per day on Aligria 2 platforms using serum samples as part of ongoing 510(k) validation work
• •Perform ELISA and other high-complexity immunoassay testing according to established laboratory protocols
• •Document all QC activities, calibrations, corrective actions, and routine maintenance with precision
• •Process proficiency testing samples alongside patient specimens, maintaining consistent handling documentation
• •Enter, verify, and release test results; perform independent verification of manual data entries before release
• •Identify issues affecting test performance or result reporting and escalate or resolve promptly
• •Perform statistical analysis of QC testing data
• •Strong attention to detail and disciplined documentation practices
• •11 more items(s)