Quality Assurance Associate/ Sr. Quality Assurance Associate

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 Senior Quality Assurance Associate or Quality Assurance Specialist who will be responsible for documenting and tracking compliance for a clinical molecular laboratory.  This individual will play an integral role in supporting quality assurance activities in accordance with FDA QMSR (Quality Management System Regulation), ISO 13485, and other applicable global regulations, including but not limited to records management, acceptance activities, production and process control. This individual also supports the QMS activities that comply with CLIA/CAP requirements for the clinical laboratories.

The shift for this position is Sunday to Thursday OR Tuesday to Saturday.

Key Responsibilities:

• Compilation of the Device History Record.

• 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/FDA requirements.

• Aid in tracking and maintenance of quality records, including batch records, checklists, and quality and equipment binders.

• 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.

Other Responsibilities:

• Assist in document control workflow, as needed.

• Manage Supplier Documentation and Compliance, as needed:

  • Proactively work with suppliers to ensure documentation on file is up to date

  • Send and Review Supplier Questionnaires

  • Maintain supplier certificates

  • Review and escalate customer and supplier notifications

  • Review documents received and escalate any concerns for further review

Minimum Qualifications/Experience

• High school diploma, Bachelor's Degree in Life Science or Engineering preferred

• 0-2 years of experience in industry or Quality or 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