Managed, verified, and controlled accurate printing, issuance, reconciliation, and documentation of 280/week product labels to ensure compliance with quality standards, regulatory requirements, and production specifications.
Oversaw preparation, inspection, and coordination of approximately 10K / week packaging materials.
Verified packaging label accuracy to Master Label Proof for 100% verification.
Created materials cost documentation to highlight and potentially eliminate or reduce unnecessary cost for the customer.
Collaborated within departments to cross-train seven individuals for better work performance.
Collaborated with Production Control to provide accurate parts list for the Production Controllers and Operations Planners.
Formerly CATALENT
Quality Control Inspector
COOK MEDICAL
Bloomington, IN
06.2012 - 01.2021
Conducted detailed inspections of incoming raw materials, in-process products, and finished pharmaceutical goods to ensure 100% compliance with FDA, GMP, and internal quality standards.
Identified and documented product non-conformances to mitigate or eliminate the problem.
Performed visual and dimensional inspections using precision measuring instruments, maintaining high product accuracy and reducing batch rejection rates.
Collaborated with Production and Engineering teams to investigate root causes of defects, helping implement corrective actions that improved overall manufacturing quality.
Maintained meticulous quality records in electronic batch records, ensuring data integrity and traceability.
Demonstrated exceptional attention to detail by detecting critical product defects before release, preventing potential compliance risks and protecting patient safety.
Lead Specialist, Quality Assurance Label Control CAR-T at Bristol Myers SquibbLead Specialist, Quality Assurance Label Control CAR-T at Bristol Myers Squibb