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Cancer Genetics, Inc. (CGI) is a rapidly expanding diagnostic, genomics research, and DNA diagnostics probe company, and a pioneer in developing disease specific CGH Arrays for cancer. We are dedicated to the mission of providing genomic solutions to the clinical, biopharmaceutical, and research communities.
Job Title: Manager, Quality Assurance
Summary: This individual will be immersed into QA systems. This position will provide exposure to both clinical (CAP, CLIA) and biopharma (GCP) regulated environments. The individual will provide broad QA support during startup operations as required with an understanding of local regulatory as well as global expectations.
* Manage the document control process on site: compiles, organizes, and tracks Standard Operating Procedures (SOPs), forms, and other regulated documents to ensure timely and accurate review and content.
* Recommend, create, implement, and update SOPs, as necessary, to improve processes, and support compliance.
* Define and implement quality standards, systems, and metrics for maintaining regulatory compliance for commercial operations.
* Support improvements and maintenance of the Quality Management System (QMS), including ensuring the system is fully functional in the laboratory while maintaining compliance with regulatory agencies.
* Ensure that all SOPs are written in accordance with GCP standards and CLIA/CAP guidelines.
* Notify technical staff of appropriate training for their respective roles.
* Conduct audits, both internal and external (vendor qualification).
* Provide support to the QA team during regulatory agency inspections or third party audits by participating in inspe