Position Summary
The Quality Assurance/Quality Control (QA/QC) Specialist provides institution-wide support for quality assurance and quality control activities to ensure compliance with regulatory accreditation and institutional standards. This role focuses heavily on clinical research oversight including compliance with Good Clinical Practice ( GCP ) while also supporting applicable pre-clinical research activities (e.g. Good Laboratory Practice GLP core facilities and translational studies). The Specialist will play a critical role in supporting Investigational New Drug ( IND ) and Investigational Device Exemption ( IDE )-enabling studies ensuring documentation data integrity and regulatory submissions meet U.S. Food and Drug Administration ( FDA ) requirements. The QA/QC Specialist works collaboratively across departments research teams and administrative offices to strengthen a culture of quality integrity and continuous improvement in research operations.
Required Experience
3 years
Work Schedule
M-F 8-5
Required Experience:
IC
Position SummaryThe Quality Assurance/Quality Control (QA/QC) Specialist provides institution-wide support for quality assurance and quality control activities to ensure compliance with regulatory accreditation and institutional standards. This role focuses heavily on clinical research oversight inc...
Position Summary
The Quality Assurance/Quality Control (QA/QC) Specialist provides institution-wide support for quality assurance and quality control activities to ensure compliance with regulatory accreditation and institutional standards. This role focuses heavily on clinical research oversight including compliance with Good Clinical Practice ( GCP ) while also supporting applicable pre-clinical research activities (e.g. Good Laboratory Practice GLP core facilities and translational studies). The Specialist will play a critical role in supporting Investigational New Drug ( IND ) and Investigational Device Exemption ( IDE )-enabling studies ensuring documentation data integrity and regulatory submissions meet U.S. Food and Drug Administration ( FDA ) requirements. The QA/QC Specialist works collaboratively across departments research teams and administrative offices to strengthen a culture of quality integrity and continuous improvement in research operations.
Required Experience
3 years
Work Schedule
M-F 8-5
Required Experience:
IC
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