David Shelly Email & Phone Number

Review and approve validation protocols and reports for equipment, cleaning processes, analytical methods, and microbial testing.Approve equipment qualifications and completed work orders in the asset management system.Receive, triage, and enter incoming product quality complaints within the QMS.Communicate investigation results to complainants and perform final closure of complaints.

Seymour, Indiana, United States

Review and approve validation protocols and reports for equipment, cleaning processes, analytical methods, and microbial testing.Approve equipment qualifications and completed work orders in the asset management system.Receive, triage, and enter incoming product quality complaints within the QMS.Administrator of the QA corrections access database.

Seymour, Indiana, United States

Perform investigations to determine the root cause of defects, impact to product on the market, and determine appropriate corrective actions to prevent reoccurence. Communicate with complainants and contract manufacturing organizations via phone, letters, and email.

Seymour, Indiana, United States

Implement changes to cGMP documents to improve usability.Collaborate with operations and QA to determine corrective actions for reoccurring and high severity issues.Investigate deviations to the manufacturing process and write technical reports within the QMS.

Seymour, Indiana, United States

Perform packaging audits, AQLs, documentation review, and identification of deviations on the manufacturing floor.

Seymour, Indiana, United States

Dispensing, Fluid Bed, Hi-Shear, Milling, Blending, Solution Prep, Encapsulation