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Quality Assurance Associate



Quality Assurance
Chicago, IL, USA
Posted on Tuesday, September 19, 2023

Passionate about making a difference in the world of cancer genomics? With the advent of genomic sequencing, we can finally decode and process our genetic makeup. We now have more data than ever before but providers don't have the infrastructure or expertise to make sense of this data. We're on a mission to connect an entire ecosystem to redefine how genomic data is used in clinical settings.

We are looking for a Quality Assurance Associate who will be responsible for documenting and tracking compliance for a clinical molecular laboratory.

Quality Assurance Associate Responsibilities:

● Read and understand SOPs within the document control system.

● File quality records in a systematic organized manner.

● Maintain documentation in order to satisfy CLIA/CAP/NYS-DOH requirements.

● Aid in tracking and maintenance of quality records, including batch records, checklists, competency assessments, quality and equipment binders, and continuing education documentation.

● Complete and maintain onboarding, offboarding, and transfer duties within electronic quality management systems.

● Maintain training matrix and training document master list, with guidance.

● Assist in document control workflow, as needed.

● Report significant deviations and system deficiencies to management, under guidance and as appropriate.

● Pull records and reports as requested during internal and external audits.

● Help facilitate and implement corrective and preventative actions.

Minimum Qualifications/Experience

● High school diploma

● Experience with clerical/documentation handling

● Highly organized and systematic, with superb attention to detail

● Ability to complete repetitive tasks with a high degree of precision and accuracy

● Proven ability to learn new skills quickly and adapt to new processes smoothly

● Good time management and communication skills

● Self-driven and works well in a fast-moving, cross-functional team environment with minimal direction

● Beginner ability to create processes, as well as suggest solutions to challenges

● Beginner computer skills and software applications, including experience with Microsoft Office tools and/or Google Suite applications

Preferred Experience

● Previous experience in a clinical lab regulated by CAP/CLIA/NYS/FDA highly desirable


We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.