Helix is building a high-throughput clinical genetics laboratory using next generation sequencing to provide genomics scale information to our clients. We're excited to deliver novel genomic insights to our customers, and the laboratory is the foundation of our ability to supply high quality, accurate and reproducible genomic data.
We are searching for a highly motivated, independent and team oriented person to drive Quality Assurance for our clinical laboratory and join our growing group in San Diego. The ideal candidate will be responsible for the laboratory Quality System at Helix and will work in a dynamic, team-oriented environment to develop robust, scalable genetic testing processes to be used in cutting-edge clinical genetics applications.
Your responsibilities are:
- Promote a culture of quality by educating and guiding the team in appropriate QA methods.
- Establish, implement and maintain clinical laboratory Quality Systems in compliance with all appropriate regulatory standards, including federal, state and local levels.
- Ensure compliance with regulatory standards and internal policies and procedures to provide effective support of laboratory operations.
- Function as the Laboratory Internal Audit Coordinator, planning and coordinating internal audits to ensure ongoing excellence in quality and service.
- Ensure regulatory compliance and accreditation readiness by maintaining up-to-date knowledge of requirements and coordinating activities to fulfill requirements.
- Facilitate the design and validation of efficient workflow processes and develop appropriate documentation (process maps/tables, procedures and forms) for QA.
- Coordinate or assist in coordinating regular quality systems meetings reviewing quality metrics. Participates in Product Quality reviews, management reviews and preparation of quality reports.
- Participate in development and validation of test methods for existing and new products in collaboration with research and development.
- Carefully documentation of testing and laboratory procedures.
- All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
- BS degree in Biology, Genetics, Chemistry, Biochemistry or related field.
- 4+ years of QA industry experience; clinical molecular genetics or in-vitro diagnostic quality assurance.
- A firm understanding of Quality Systems, CLIA regulations and CAP regulations.
- Experience in successful CLIA and CAP regulatory audits.
- Effective interpersonal and communication skills and capable of supporting cross-functional project goals
- Careful and accurate documentation of work.
An ideal candidate will also have:
- Familiarity with FDA Quality System Regulations and ISO Standards (ISO 13485, ISO 15189) and HIPPA are highly desired. Experience with NY, CLEP and any additional agencies would be beneficial.
- Possess an understanding of the fundamental principles and concepts of molecular biology (specifically next-generation sequencing), genetics, and how these relate in a clinical setting.
- Motivated, enthusiastic, hard-working, positive individual who desires to be part of a fast-paced, dynamic development environment.
- Excellent problem solving and reasoning skills.
This is a fantastic opportunity to help Helix develop a state of the art, high throughput, NGS-based clinical production laboratory. If you like the idea of establishing and optimizing a production scale clinical laboratory, then this is the ideal opportunity for you.