US-CA-Pleasanton: Quality Assurance Audit Coordinator
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Quality Assurance Audit Coordinator
Maintains records and assists with inquiries related to the QHR and Receiving Inspection Process Audits
Adheres to documented audit procedures, audit schedules and report forms.
Assists in planning and preparation for audits
Completes the Final Audit Report form
Provides data on findings to inspectors as requested
Records and maintains files associated with corrective actions, responses and plans
Completes procedures for close out activities and follows up regarding outstanding items.
Files and maintains the audit schedule and reports.Other QA Projects
Maintains and organizes QHR files for retrieval and archival activities
Maintains and organizes RI tools/equipment for inspections and calibration activities
Reviews Non Conformance Reports against identified criteria for correctness and completeness, prior to submission to the NCR Distribution List
Supports training activities as needed.
Participates in simple part inspections as identified by procedural documentation.
Gathers data related to issues and discrepancies as part of the investigations and resolutions process in Receiving Inspection.
Provides input for and maintains the Daily Priorities List for use in next day activities.
Provides input for process improvements, striving to increasing efficiency and thru-put of the department.
2 years of college, AA degree or equivalent education and experience.
3-5 years of work experience related to Quality Assurance / Quality Control.
2 years serving in an audit support function.
Working knowledge of Microsoft Excel and Microsoft Word
Strong organizational skills, excellent communication skills, and attention to detail
Understanding of FDA Regulations/cGMPs (21 CFR Part 820) and ISO Standards
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