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.