Casey Heckard

Reviewed batch documentation to ensure cGMP and GDP compliance Conducted QA audits of personnel, processes, and equipment Created, reviewed, and approved controlled documents in EDMS

QA Floor Support - CATALENT (Novo Nordisk)

(2022-01 - 2026-01)

• Reviewed batch documentation to ensure cGMP and GDP compliance
• Conducted QA audits of personnel, processes, and equipment
• Created, reviewed, and approved controlled documents in EDMS
• Managed deviations, CAPAs, and effectiveness checks in TrackWise
• Approved work orders and managed equipment status in Maximo
• Performed in-process inspections (AQL) for manufacturing and packaging
• Approved qualification test sets and validation protocols for inspection processes
• Released packaging kits in label control
• Provided real-time QA support to maintain product quality and minimize disruptions

Aseptic Fill Room Operator - BAXTER

(2004-01 - 2022-01)

• Maintained cGMP/GDP compliance and accurate documentation practices
• Performed batch record reviews, line clearances, and equipment cleaning
• Conducted sanitization and ensured contamination control procedures
• Operated and set up manufacturing equipment per SOPs
• Cross-trained across preparation, formulation, capping, packaging, and inspection
• Maintained PPE use and gowning qualification for Grades A–D environments
• Managed material tracking, verification, and release in JDE/ERP systems
• Supported Six Sigma initiatives for process improvement

Graduate - Shoals Jr/Sr High School (1994-01) Shoals, IN

Ivy Tech Community College (1999-01 - 2001-01) Evansville, IN