Job Title: Quality and Regulatory Affairs Scientist I
Department: Regulatory Affairs Department
JOB RESPONSIBILITY SUMMARY
Insight Genetics is dedicated to client satisfaction and continual improvement. The Quality and Regulatory Affairs Scientist I is an entry level position responsible for the effective management of Insight Genetics’ Quality Management System processes internally and implementation with Insight Genetics’ external clients. The employee should have basic knowledge and understanding of national and international quality standards including ISO 9001:2008, ISO 13485, Clinical Laboratory Standards Institute (CLSI), Clinical Laboratory Improvement Amendments (CLIA), FDA Quality System Regulations (21 CFR 820), regulatory and legal frameworks, processes and procedures, and begin to develop the critical thinking skills essential to the profession. The Quality and Regulatory Affairs Scientist I will be responsible for the following activities upon completion of orientation and training:
Lead efforts for third party inspections and accreditations.
Management of electronic document control system.
Establish project plans leading to regulatory certifications.
Writing and review of technical reports, SOPs, design control documentation.
Management of grant submissions.
Direct support of all technical and scientific regulatory activities.
May act as the Quality Management System management representative.
The Quality and Regulatory Affairs Scientist I will also provide scientific and quality/regulatory support for Insight Genetics’ Biomarker Decision Support System (BDSS), CLIA laboratory operations, and customer-related interactions, reports and documentation. Effective interpersonal relations and the ability to communicate complex scientific concepts are a must. A life science background and understanding of basic statistical concepts are also required to ensure competency in Good Laboratory Practices and Procedures.
REQUIRED/PREFERRED KNOWLEDGE, SKILLS, & ABILITIES
Required: M.S. or Ph.D. in a life science/technical area.
Preferred: Molecular Biology, Biochemistry, Genetics, Genomics.
Required: 4 year post-secondary education, or equivalent experience.
Preferred: 3-5 years’ experience in a regulated industry or may consider related areas: quality assurance, research and development/support, scientific affairs, or operations.
Special Knowledge/ Skills
Required: Superior written and verbal communication skills.
CVs can be sent directly to Rachel L. Skelton, PhD, Regulatory Scientist I, Insight Genetics, Inc.
Two International Plaza, Suite 510
Nashville, TN 37217