Jonathan Fronczak

Quality Assurance Compliance Specialist @Pine Pharmaceuticals

Collaborates productively across all branches of the organization to ensure site compliance of all corporate Policies and Standard Operating Procedures (SOP), as well as conformance to all regulatory requirements, including cGMP standards, USP Guidelines and FDA regulations •Independently and accurately investigates quality/noncompliance events, including but not limited to Nonconformances, Deviations, Out of Specification (OOS), etc, performing all investigations in an expedient and timely manner •Conducts Customer Complaint investigations, including Adverse Drug Events, preparing and submitting a root-cause analysis reports to the Director of Quality Assurance •Accurately performs risk analysis and identifies impact through studies on products and processes, with an overriding focus on the potential effects on patient health and safety •Implements effective root-cause analysis tools to identify the origins of adverse events and suggests appropriate follow up actions including CAPA and related effectiveness checks, as well as product safety and disposition •Collaborates on substantiating data/evidence for additional documents under the Quality umbrella to effectively update or create new SOP’s, including but not limited to the application of such SOP’s for the development of validation and stability protocols, as well as to update Drug Master Files (DMFs) in addressing and resolving deficiencies •Collaborates with management to identify and implement corrective measures to rectify cGMP inadequacies to prevent recurrence of chronic adverse quality events, as well as promote practical process improvements