Macrogen Corp. is looking to hire an QA/RA Specialist with experience in the clinical laboratory industry. This individual’s primary function would be to handle the company’s domestic and international regulatory affairs, mostly CLIA, ISO, cGLP, and GLP. This individual will also play a supporting role in quality assurance and be flexible enough to take on other assigned tasks.
- Stay current with all regulatory procedures and documentation in order to maintain compliance with GLP, ISO, CLIA and customer requirements.
- Develop Standard Operating Procedures and practices to optimize quality, safety, and reliability of clinical sequencing workflow.
- Work with Laboratory operations to develop validation protocols.
- Ensure compliance of quality of results and direct report to the technical supervisor and laboratory director.