Quality Assurance Assistant
Employment Type: Full-Time
Supports the QA Supervisor in maintaining and improving the basic functions of the Quality Management System
- Responsible for document management system and document changes as part of the Quality Management System; including drafting, routing for approvals, distributing current revisions, recording document change training, following up on past due items.
- Responsible for facilitating monthly gauge calibrations; including distributing lists of gauges due, communicating with calibration contractor and internal personnel, reporting gauge issues, issuing new gauges, and updating gauge records in gauge tracking system.
- Proposes and facilitates improvements to QMS utilizing continuous improvement tools.
- Facilitates changes to records in ERP system.
- Assists in facilitation of tasks related to corrective action system, including following up on tasks with task owners, facilitating follow up meetings, entering data into CAPA system.
- Assists with administration of Item Review Board process.
- Completes quality checks deemed necessary as a result of quality issues or initiatives, including auditing of finished goods for quality parameters and quality checks during the production process.
- Manages storage of quality system records (paper and electronic).
- Ensure that Process Document Changes (PDCs) are completed correctly and in a timely manner.
- Ensure that gauge calibrations are completed and information logged correctly and in a timely manner.
- Ensure that quality records are maintained and stored correctly according to quality procedures.
- Support QA Supervisor in managing the Quality Management System.
NATURE AND SCOPE
Required Knowledge and Skills
- Minimum Associates degree or 2 years applied experience preferred
- Fluent in use of Microsoft Word and Excel; experience with Quality software/ERP systems a plus
- Excellent visual acuity and attention to detail
- Excellent verbal and written communication
- Quality Assurance experience or training a plus
- Learning information systems and process flow
- Identifying gaps in QMS processes and providing solutions
- Calibrations due reports, overdue task reporting, other reporting as assigned by QA Supervisor
Major or Unusual Problems
- Understanding interaction of all departments with Quality Assurance and developing communication skills to properly collaborate with others who use the QMS
Contacts Within and Outside the Organization
- INSIDE: All departments as required
- OUTSIDE: Calibration contractors
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