Quality Document Specialist

Basic Function:

Join a dynamic Fortune 200 retail manufacturer where you will gain Quality Assurance experience. Work closely with the Quality Assurance team to have oversight of all Document Control and Records Management functions for the company. The Quality Document Specialist will play an integral part in the success of the entire organization.

Key Responsibilities:

• All aspects of the document management system within the Electronic Quality Management System (eQMS)
• Coordinate and independently process internal documentation including but not limited to: SOP's, Work Instructions, Forms, Batch Records, Methods, etc.
• Become a subject matter expert on the document management system with the eQMS. (AlisQi) so you can provide guidance to users on document authoring and revision.
• Scan and process executed batch records, COAs and other documentation into the eQMS.
• Assist with the creation and reporting of metrics and internal KPI's related to the document management system.
• Create and manage document hierarchy and process systems.
• Take charge of all document identification, classification, and filing
• Frequently conduct document audits confirming they are current and accurately reflect recorded evidence.
• Ensure revised documents are accessible.
• Conform to company enforced specifications and document control procedures.
• Train employees in the company’s-controlled document processes to ensure correct handling of documents from the ground up.
• Oversee document through its entire lifecycle (inception to archival)
• Check and edit incoming documents and prepare for distribution.
• Make available, notify, and distribute documents to relevant recipients.
• Confirm delivery of documents to proper personnel
• Collaborate and communicate with managers and project leaders.
• Identify and implement document control process improvements to ensure compliance with internal and regulatory requirements.
• Participate in the periodic maintenance and upgrades to the document management system including revising procedures and performing validation activities.
• Provide support during regulatory inspections as well as internal/external audits.
• Other duties and responsibilities required per the Quality Management System, including assistance with product inspection, testing, sorting, and providing back up for Quality Technicians as needed

Requirements

Minimum Qualifications:

• Must have strong verbal and written communication skills.
• Computer literate and excellent organization and time management skills.
• Demonstrated ability to work efficiently with minimal supervision.
• Proficiency with email, word processing, spreadsheet, and presentation software.
• Ability to quickly learn and process information.

Additional Preferred Qualifications:

• Previous experience in an administrative capacity.
• Experience in the Manufacturing industry.
• Previous experience working in an ISO 9001:2015 environment.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job. This job description should not be construed to contain every function/responsibility that may be required to be performed by an incumbent in this position. Incumbents are required to perform other related functions as assigned.