Max Lit Email & Phone Number

New York, New York, United States

New York City Metropolitan Area

New York City Metropolitan Area

New York City Metropolitan Area

Greater New York City Area

Greater New York City Area

Raleigh-Durham, North Carolina Area

- Supported and maintained all aspects of the Quality System in accordance with the company's quality manual, SOP's, and customer requirements.- Took on contributor/supporting role in process definition or re-engineering for continuous improvement of operating procedures and processes.- Provided value-added day-to-day support, guidance, and direction to teams on matters of regulatory and process compliance in service of international clinical trials.- Was responsible for escalating medium, high, and critical severity issues to QA Management.- Supported customer audits as needed. Participate/support whenever required.- Led internal audits and investigations to ensure that Quality Standards were being adhered to. - Supported ongoing training and support for new and existing staff on the Quality Manual and other key areas including Corporate SOP's, GCP, 21 CFR Part 11, validation, and process improvement/problem solving. - Assisted in the maintenance of the corrective/preventive action program (CAPA), inclusive of tracking status of open actions, receiving and reviewing responses, working with departments for timely completion and periodic reports/metrics.- Assisted and/or maintained status tracking of internal audits and responses, sponsor audits, and vendor audits.- Supported the company during external inspections as required.

Princeton, Nj

• Assess clinical trial data for accuracy and compliance with BioClinica, Inc. Standard Operating Procedures• Coordinate and oversee distribution of documents and reports to be reviewed by Global Quality Management• Perform internal audits to ensure data integrity, compliance, and continual improvement to processes• Review all associated documentation for accuracy and conformance• Reviews, approves and analyzes both internal and external compliance-related issues and reports such as corrective and preventive actions (CAPA), deviations and notes to file (NTF)• Ensure all compliance issues are tracked and trended as well as closed in a timely manner.• Track and report quality concerns and problems to the Manager of Global Quality Management• Act as a resource to staff for imaging issues and management• Communicate effectively, verbally and in writing, with all internal and external clients• Responsible for his/her continuing professional education