Clinical Laboratory QA Associate

Organization
Helix
Job Location
9875 Towne Center Drive
San Diego, CA 92121
Benefits

What Helix has to offer you

Aside from working alongside brilliant, dedicated, passionate, down-to-earth, curious, warm, and thoughtful people, we also provide great benefits:

  • Competitive compensation, including meaningful equity
  • Health insurance, including medical, dental, and vision
  • 12 weeks of Maternity or Paternity leave
  • 401(k) with employer matching
  • On-premise nursing room
  • Corporate fitness rate
  • Commuter benefits
  • Catered meals
  • Flexible PTO
Job Description

Helix is seeking a motivated and experienced Clinical Laboratory QA Associate to join our team.  This position will be part of the Helix Regulatory and Quality Affairs team.  This individual will have the opportunity to implement laboratory quality processes in our state of the art clinical laboratory in San Diego.

This position provides a unique opportunity to make an immediate impact, and lay the foundation for processes and procedures in a fast-paced dynamic environment. If you are looking for the opportunity to provide your expertise and make a significant contribution, this role provides an empowering and action-oriented environment to take your career and our mission to the next level.

If you are interested in applying your compliance knowledge to a company that is poised to bring cutting-edge technology and novel products to the market, join our team. This position will be located at our CLIA-certified clinical laboratory in San Diego.

As a Clinical Laboratory QA Associate, you will:

Support the Quality function in the execution and maintenance to the following quality system activities:

  • Writing, editing and review of SOPs to ensure documents comply with applicable regulatory requirements.
  • Perform document control activities.
  • Review of documentation/records for accuracy, completeness and to ensure good documentation practices are followed.
  • Create and perform compliance training for laboratory staff.
  • Preparation and maintenance of training files.
  • Assist laboratory team with creation of equipment maintenance procedures and logs as well as IQ/OQ/PQ documentation.
  • May lead or assist with investigations to determine root cause analysis and ensure that effective corrective and preventive plans (CAPA) are put in place.
  • Helps identify and implement changes to Quality System to support system improvements.
  • Performs and document internal audits and make recommendations for corrective actions.
  • Compile and trend pertinent QA metrics.
  • Participate in regular quality meetings.
  • May participate in or provide support during audits and regulatory inspections. 
Requirements
  • Bachelor’s degree in Science or related technical field required
  • 3 + years Quality Affairs associate working in a Quality team in a CLIA/CAP laboratory
  • Working knowledge of federal, state and local laboratory regulations
  • High level of competency in Microsoft Office applications (Word, Excel, Adobe Acrobat)
  • Experienced with automated document control systems
  • Strong organization skills and ability to multi-task various projects
  • Strong analytical and problem solving skills
  • Strong written and oral communication skills
  • Able to deliver quality outputs under deadlines
  • Able to work in a fast-paced environment while managing multiple priorities
How to Apply
About Our Organization

We believe that everyone benefits from their biological information. It’s our mission to empower every person to improve their life through DNA. With our high-quality, trusted partners and state-of-the-art lab, we’ve created the first platform of personalized products and services powered by genetics. From inherited cancer screening to custom fitness and nutrition plans, the world of DNA learning is becoming more accessible and more valuable than ever.

So far we’ve raised over $100 million from investors like Illumina (the world’s leader in genetic sequencing equipment), Warburg Pincus, Sutter Hill Ventures, and Kleiner Perkins. Our app store and marketplace include partners such as National Geographic, Admera Health, Vinome and many others, with whom we have partnered to develop applications which interpret your genome.

Our big vision comes with big responsibility. That’s why we’re building a team of experts in the field of genetics, engineering, design, business development, and beyond to help bring actionable insights to our customers. We’re looking for the best and brightest minds who are passionate about our mission and are excited to work with a truly diverse team.

 

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