Daniel Burns Email & Phone Number

Allentown, Nj, Us

New Jersey, United States

Assuring business operations and controls are in compliance with ISO9001, SOC2 Type 2, GDPR, HIPAA; assuring software product design and testing conform to applicable regulations including 21CFR Part 11 and Eudralex Vol. 4 Annex 11; developing and managing internal QMS to deliver robust and reliable SaaS solutions to the highly regulated Life Sciences space.

Hamilton, New Jersey, United States

Driver of near and long-term strategy for Trackwise Digital

Dayton, New Jersey

Point of contact for FDA and customer audits; responsible for all phases of Quality Assurance for manufacturing and packaging operations; responsible for Quality Management System and Quality Risk Management programs, including but not limited to Change, CAPA, and Supplier/ Vendor management.

Princeton

Day to day oversight of investigation, CAPA, change management systems; Labeling approval for OTC/ Rx products; Management of product complaint team, including trend identification and analysis; Development, validation, and deployment of applications for label change management and control and medical inquiry/ adverse event/ product complaint intake and evaluation.

Princeton, New Jersey

Responsible for administration of change management, document control, investigations and deviations, CAPA, SOP, and other quality systems; computer systems validation and management; stability program support and improvement.

Responsible for overall QC Lab compliance to in-house and cGMP requirements, specifically instrument qualification and calibration, investigation/ deviation/ CAPA, Empower implementation/ validation, procedural revision/ creation/ training, and method validation activities. Responsible for review/ approval of test methods, specification reports and testing documentation. I supervise the metrology and data review staff, in order to ensure lab efficiency.

Responsible for oversight of the commercial stability program, including environmental chamber qualification, monitoring, and excursion response as well as program administration including protocol creation, pull-schedule maintenance and adherence,and testing results tabulation and trending. Responsible for the laboratory instrument calibration and qualification program. Liaison with Quality Assurance for QC Change Controls, SOP, Investigations, and CAPA.

Active participant in our consent-decree remediation, including incorporation of a comprehensive instrument qualification and calibration program, revision of stability procedures and protocols, implementation of procedures pertaining to controlled substance (DEA) handling and documentation, and a review of general lab practices.

AR&D Chemist responsible for routine testing of stability samples, instrument set up and breakdown, and use of automated sample preparation "robot".