Responsible for general supervision of the manufacturing inspection and test functions at every stage of the manufacturing process.May supervise inspection and test activities of operators.Performs function failure testing as well as physical defects.Oversees operational implementation of quality assurance strategies and regulations.Completes the assessment of potential risks, ensures compliance and gives recommendations to management.Supervises team to ensure quality control aspects of the process are met (labouratories studies, clinical research, testing, operations, raw materials, production, finished product or services).Facilitates audits and regulatory inspections.Liaises with external vendors, contractors or suppliers to ensure that their products or services meet the organisation's quality standards.

Team Lead:Calculate and compile weekly batches as needed. Coordinate work order and supporting documentation updates. Review and sign off completed work order updates. Track and identify batches under the Infant Formula Act Surveillance program. NPI (New Product Introduction) Coordinator:Attend meetings for new products for the Columbus plant and assess plant impact. Implement new projects into a tracking database. Track individual components of each new product against project timeline. Conduct weekly NPI meetings to convey project information with all supporting areas of the Columbus plant.

Review and audit batch records for completeness and FDA compliance. Initiate Exception Reports for non- conformities in the GQMS system. Maintain Exception Report readiness file for FDA audits Ship and monitor surveillance samples. Write and audit statistical sampling plans to test the effectiveness of an inspection. Write and audit rework packets Send out daily audit reports. Complete Batch Record Reviews for open RPICs. Back up person for Plant Complaint Investigations.

Incoming Review packaging slips, Certificates of Compliance, and commodity specifications for accuracy and completeness. Inspect and measure incoming commodities using various instruments such as: CMM machine, Optical comparator, Instron machine, calipers, voltmeter, and pin gages. Approve and release commodities in the SAP and AMAPS inventory systems for use in production and shipping departments. Maintain an acceptable environment within the lab per all FDA, ISO regulatory compliance guidelines. Initiate Exception Reports for non- conformities in the GQMS system and change requests in the QDMS system when applicable. Create and maintain labels as an administrator within the label system for all new and existing specifications. Create and maintain programs as the SME for the CMM machine Train and certify individuals on the Acceptability of Assemblies per the IPC- A- 610 Standard. Assume some Coordinator duties in their absence.

Supervised all support services related to quality and production, including auditing, error proofing, sequencing, inspection, and quarantine of non- conformances. Maintained processes and documentation within an OSHA, EPA, and TS / ISO regulated environment. Trained, supervised, and evaluated a 19- person integrated team. Teamed with other departments within the production facility to support Lean- Six Sigma projects.