Quality Assurance Regulatory Affairs Specialist I

Organization
Macrogen Corp.
Job Location
1330 Piccard Drive
Suite 103
Rockville, MD 20850
Salary
Discussed during interview
Job Description

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.

Duties:

  • 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.
Requirements

Qualifications and Certifications:

  • Bachelor’s degree, biology or related field preferred but not required
  • Familiarity with CLIA, cGLP, GLP, ISO 13485 requirements, and international quality regulations
  • Previous experience in quality assurance and regulatory affairs for clinical settings preferred
  • Mastery of computer software including Word, Excel, PowerPoint
  • Superior communication skills in English, verbal and written
  • Ability to handle many projects at once, work under pressure
  • Ability to read and speak Korean is a plus but not required
  • Strong Organizational skills

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