Quality / ISO Systems Administrator at SafeRack, LLC

Posted in General Business 14 days ago.

Type: Full-Time
Location: Andrews, South Carolina





Job Description:

Position Summary:
Reporting directly to the Quality Team Leader, this position will support an ISO 9001-compliant Quality management system, driving compliance to QMS processes and continual improvement actions. Assess and reports Quality System performance to appropriate management for review/action as needed. Coordinate training and coach personnel in Quality Management System requirements and conduct ISO/Good Manufacturing Practice training. Obtain/maintain 9001:2015 auditor certification for internal auditing activities.




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Essential Duties and Responsibilities:

· Serve as Document Management System (eDMS) and document management subject matter expert to the site assisting users with questions and issues
o Using the electronic DMS, review and format quality system documents, cGMP SOPs, forms, and other documents as necessary
o Ensure adequate document control through use of the eDMS including setting effective dates and periodic review dates
· Ensure adequate document control through use of the eDMS including setting effective dates and periodic review dates
· Manages Change Control process compliance and ensures timeliness in the routing of Quality Management System Documents.

Coordinates with 1st Responder and Quality Team Leader to investigate customer complaints and all applicable information to determine accuracy of a complaint, document investigation findings, and drive steps to complaint resolution in a timely manner.
Via Non-Conformance Reporting, collects and organizes customer complaint data related to possible trend and distributes for plant visibility.
Contributes ideas and suggestions to improve standard, products, processes, packaging, shipping methods, services, and procedures to prevent future complaints of similar nature,
Coordinates for the site: Change Management, Document Control, CAPAs (MRB)/NCRs.
Assists in the continuous evaluation of the quality system for compliance to ISO 9001:2015 and internal processes/policies.
Responsible for proper control of documentation and quality records.
Prepares QMS performance reports for Management Review Meetings.
Maintains and ensures the confidentiality of information/ materials.
Support customer/3rd party audits of the site.
Other duties as business needs dictate.




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