In this role, you will support the organization in monitoring of the compliance of laboratory testing, manufacturing, and clinical research and ensuring continued effectiveness of the QMS according to CLIA, CAP, HIPAA, GLP, GMP, and QSR requirements.
In this role, the selected candidate will prepare appropriate documentation and executes release of acceptable vendor materials; review completed analytical data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
As the Quality Assurance Specialist you will lead initiative to track, oversee and manage the employer confirmation process by working closely with the Senior Account Manager as well as the Sales and Recruitment teams to ensure timely submission of employer confirmations and compliance with the New York City Department of Small Business Services policies.
In this role, you will be responsible to act as a Subject Matter Expert for Quality Systems, programs and procedures. Provide daily oversight, guidance and support in regards to Quality Systems, Quality Policies and Procedures.
In this role, the selected candidate will act as a QA representative on associated projects related to Quality laboratory operations; ensure clear communication on issues and timely escalation as applicable.
In this role, the selected candidate must have an excellent understanding of 21 CFR Part 11, ICH standards, EMEA, GLP, GCP, GMP, GDP regulations, GAMP Methodologies and general software development standards.
In this role, the successful candidate will work constructively with cross-functional departments for timely resolution of quality issues; support activities and documentation related to corrections, corrective actions and preventive actions to correct and eliminate the potential for non-conformances.