Corey Delaney Email & Phone Number

Morgantown, West Virginia, United States

Direct and manage the performance of department staff for 120+ employees. Provide Operational Management and ensure Data Integrity compliance for all Quality Systems in the QC Laboratory. Manage Analytical Investigations, Data Analysis and Review, Reference Standard Qualifications, Stability Programs, Document Control, Change Management, and Sample Management.Oversee the testing of Raw Material, In-Process, and Finished Product samples.Support Product Launches, Process and Method Validations, and Analytical Method Transfers.Prepare Field Alert Reports (FAR) in response to deviations and out-of-specification stability data.Participate in cGMP and Controlled Substance Audits performed by domestic and international regulatory agencies.Successfully completed (achieved VAI status) remediation following FDA issued Warning Letter.

Morgantown, West Virginia, United States

Oversaw the Laboratory Document Control System. Collaborated with cross-functional teams to assess Method Validation activities and manage revisions to analytical documents. Led teams supporting Change Management evaluation and implementation for:• Raw Material Alternate Sources and Site/Process Changes• Compendial Updates (USP, PF, EP, BP, etc.)• Domestic and Global Analytical Method Transfers• New Product Launches and Process Performance Qualification (PPQ)• Stability Rationalization and Product Shelf-Life Extensions (in accordance with ICH Q1E)

Morgantown, West Virginia, United States

Supervised the Reference Standard and Raw Material testing teams. Responsible for the general organization of resources and personnel. Performed data analysis, audited data and documentation, generated metrics, and prepared protocols and summary reports.

Morgantown, West Virginia, United States

Responsible for the leadership of laboratory teams and the testing of Raw Material, In-Process, and Finished Product samples a cGMP laboratory. Organized and maintained inventory of Reference Standards and Impurity Materials.

Morgantown, West Virginia, United States

Performed testing by High Pressure Liquid Chromatography (HPLC) utilizing UV Vis, Refractive Index, Conductivity, and Electrochemical detection. Maintained, reviewed, and audited instrument logbooks, laboratory worksheets, and all relevant documentation according to cGMP documentation practices.