Quality Auditor Professional Services - Tampa, FL at Geebo

Quality Auditor

Overview
Conduct the audit of in-process batch records and final review/release of packaging batch records/finished product. Review and approve equipment sterilization records. Issues certificates as required by company/customer requirements. Maintain the MQA database, Lot Tracking, Certificate database and batch record retention program. Assume the responsibility for the GxP, ISO and Environmental Health and Safety procedure awareness, and compliance within the respective area.
Responsibilities
1. Conduct final review/release of packaging records/finished product.
2. Conduct review of in-process manufacturing batch records/sterilization records.
3. Assist with the preparation of Certificate of Analysis/Conformance/Manufacture.
4. Maintain the MQA database, Lot Tracking, Certificate database and batch record retention program.
5. Maintain department SQMs and metrics.
6. Coordinate SIQH closure with applicable departments.
7. Identify and request applicable information from other departments required to close out records.
8. QA liaison with Manufacturing for batch record error tracking.
9. Any other duties as assigned.
Qualifications
BS (Natural Sciences). Ability to work independently. Ability to communicate and work well with others. Familiar with component and label testing techniques. Knowledge of sampling plans and GxP compliance requirements. Knowledge of inventory systems preferred.
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