• Perform external audits of CMOs/suppliers to appropriate criteria, report findings and develop actions as required.• Develop, edit, and implement QA Procedure• Analyze non-conforming materials and returned goods and recommend disposition and corrective actions.• Create and edit suitable data analysis tables and report findings based on statistical evidence and trending.• Provide analytical investigations and develop root cause for non-conformance and deviations.• Analyze data and compose summary reports (Engineering Test Files).• Interface with vendors as required• Review documentation for completeness and accuracy• Assist in the performance of qualification and validation studies

Ensures GLP bioanalytical, toxicokinetic and pharmacokinetic laboratories and associated functions meet all GLP requirements for nonclinical and clinical study sample analyses.Ensures that BA and TK reports meet GLP requirements and SOPs and protocols.

Verified compliance to applicable SOPs and GLP and GCP regulations by performing study protocol, data, reports, and in-phase laboratory inspections.Lead process improvement and facility audits.

*Audits: QPS and client protocols, analytical procedures, SOPs, experiments, study records, reports, personnel records, equipment, laboratory records, deviations and investigations, and facility for compliance with client requirements, SOPs, GLPs.*Provide audit reports to management and Principal Investigators*Provide compliance support to Operations.*Train QA staff in new audit disciplines, facility and process audits*Assist with client and government audits as requested by supervisor or manager.

*Wrote and provided management with weekly, monthly and quarterly reports regarding cycle time and backlog information for each project using MS Access.*Batch Log folder review to ensure completion prior to drug shipment.*Ensure sample log in information was transcribed to MS Access/Excel*Trackwise was used for SOP training*GMP enforced

Conducted Content Uniformity analyses using HPLC(Agilent-ChemStation/ChemStore)Trained on Dissolution/HPLC system, the electronic notebook and GMP guidelines

Program Management: Sample tracking, Data Coordination, Reference StandardsDocumentation: Wrote analytical request/report forms for batch record release of raw materials, drug substance and finished product (MS Access, LIMS databases);Conducted transcription checksTranscribed external analytical data into LIMS/MS AccessObtained quotes from contractorsReviewed invoices for testing paymentInventory: received/distributed GMP and non-GMP samples requiring internal and external analytical testing; ordered reference standards, monitored expiration, maintained logbooks.Training: trained staff on the operation of MS Access samples database.

Program Management: Metrology, Sample Tracking, Reference StandardsStability Program Liason: Monitored chemical storage/labeling/expiration and refrigerator/freezer temperature chartsDocumentation Composition: Protocols, SOPs, Specifications, CoAs to support the release of raw materials, drug substances and products; wrote method validation and results reports for drug substances/products; wrote Out of Tolerance and Out of Specification responses. Composed stability trend analysis for the submission of an Abbreviated New Drug Application with the FDA.Audits: facility and equipment; composed CAPA responses for external auditsInventory: Managed sample trackingLaboratory: conducted cleaning verification studies and wrote validation reportsTraining: trained staff on SOPs upon completion of revisions.GMP enforced

Managed Programs: Sample tracking, metrology, reference standard, stabilityAudited facility and equipmentComposed CoA for release of materials, specifications for standards, drug substanceTrained staff on SOPsLaboratory: conducted: assay, purity, stability, method transfer analyses of drug substance, drug products, reference standards, raw materials and intermediates; IQ/OQ/PQ

Developed statistical experimental design for test method optimizationConducted test to support product development (Gel Permeation Chromatography, HPLC)