Customer Complaint handling to meet cGMP and ISO 13485 regulatory requirements and B&L policy. Release finished goods to distribution. Issuing materials to production. Perform calibration of equipment.
Enter complaints and product evaluations in the electronic system. Coordinate product evaluations with manufacturing. Conduct investigation as appropriate for each complaint request. Enter plant evaluations / investigations related to Unilens complaints in the electronic system.
Perform review and verification of records prior to lot/batch release. Communicate batch hold or release status in a timely manner to appropriate personnel. Prepare and complete batch record processing for final release.
Maintain status of stockroom inventory using controlled issuance logbooks.
Perform minor internal calibration activities.
Assist and participate in internal audits and audits by external agencies (e.g. Notified Body, State DOH, FDA).
Issue non-conformances and apply corrective and preventative actions as required.
Education: Associate degree or 2-7 years of experience in Quality System Regulations and documentation for compliance.
Training to ISO 13485 and GMPs required.
Full computer literacy in spreadsheets, word processing and data entry.
Ability to effectively communicate with coworkers in a productive manner.
Well organized with ability to multi-task and shift priorities as needed to meet customer demands.