Overview:
The Quality Systems Coordinator ensure the integrity and compliance of Praxis’ quality management system in accordance with company procedures and FDA 21 CFR Part 211 requirements. This role supports the Quality Systems Manager by administering key quality programs, including Document Control, Change Control, Records Management, Investigations, Audits, Food Safety, Annual Product Reviews, Regulatory Filings, and Continuous Improvement initiatives. The coordinator is responsible for accurate documentation, effective implementation of quality processes, and supporting a culture of quality and regulatory compliance across the organization.

Responsibilities:

• Processes and maintain controlled documents (Policies, SOPs, Work Instructions, Test Methods, Packaging Specifications, Forms, Standards, Job Aids, Templates, Placards and Master Lists) to ensure compliance and system integrity. changes to SOP’s, Work Instructions, Packaging Specifications and Forms, upon request.
• Ensures document changes are accurately written, and changes are effectively implemented within all affected documents to ensure quality system integrity.
• Ensure all controlled documents comply with Praxis approved format(s).
• Ensure current and previous revisions of Controlled Documents are properly maintained and controlled.
• Performs significant technical writing, editorial, and document streamlining and consolidation duties, according to project and/or internal customer needs.
• Maintains Major Equipment and Portable Equipment Line Logbooks electronically in ETQ after they have been verified by the Quality Auditor (or above).
• Issues Major Equipment and Portable Equipment Line Logbooks.
• Scans, logs, and maintains electronic documents in ETQ as specified in Praxis procedures, to meet requirements in the Record Retention Schedule.
• Scans, Stores and manages all relevant document control workflow reports and outputs (document change requests, change control requests, deviations, etc.) electronically.
• Processes, logs and follows up on Reports in ETQ to ensure compliance with applicable requirements.
• Maintains all Document Control Master Lists.
• Responsible for adherence to all Company policies and procedures.
• Supports improvement of the quality management system using the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions.
• Instills a sense of quality through modeled quality behaviors and mindset.
• Elevates complaints and problems, seeking Management assistance when needed.
• Ensure proper PPE’s and Safety procedures are followed.
• Files completed records in the Quality Records area or in ETQ, as directed by Praxis Procedures.
• Purges, documents, and destroys retired record per Praxis procedures record retention(s).
• Assists with review of final Batch Record paperwork for accuracy and report Batches to customer as assigned.
• Assists with Internal and External audits as assigned.
• Flexibly work other shifts, shifts maybe 8, 10 or 12 hours as needed.

Qualifications:

• High school diploma or equivalent required.
• Associate or bachelor’s degree required, or equivalent experience in Quality/Document Control
• 2-4 years of experience in document control or similar experience.
• Strong organizational skills with ability to manage multiple priorities independently.
• Basic Mechanical and mathematical aptitude required.
• Ability to organize priorities and workload required.

• Processes and maintain controlled documents (Policies, SOPs, Work Instructions, Test Methods, Packaging Specifications, Forms, Standards, Job Aids, Templates, Placards and Master Lists) to ensure compliance and system integrity. changes to SOP’s, Work Instructions, Packaging Specifications and Forms, upon request.
• Ensures document changes are accurately written, and changes are effectively implemented within all affected documents to ensure quality system integrity.
• Ensure all controlled documents comply with Praxis approved format(s).
• Ensure current and previous revisions of Controlled Documents are properly maintained and controlled.
• Performs significant technical writing, editorial, and document streamlining and consolidation duties, according to project and/or internal customer needs.
• Maintains Major Equipment and Portable Equipment Line Logbooks electronically in ETQ after they have been verified by the Quality Auditor (or above).
• Issues Major Equipment and Portable Equipment Line Logbooks.
• Scans, logs, and maintains electronic documents in ETQ as specified in Praxis procedures, to meet requirements in the Record Retention Schedule.
• Scans, Stores and manages all relevant document control workflow reports and outputs (document change requests, change control requests, deviations, etc.) electronically.
• Processes, logs and follows up on Reports in ETQ to ensure compliance with applicable requirements.
• Maintains all Document Control Master Lists.
• Responsible for adherence to all Company policies and procedures.
• Supports improvement of the quality management system using the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions.
• Instills a sense of quality through modeled quality behaviors and mindset.
• Elevates complaints and problems, seeking Management assistance when needed.
• Ensure proper PPE’s and Safety procedures are followed.
• Files completed records in the Quality Records area or in ETQ, as directed by Praxis Procedures.
• Purges, documents, and destroys retired record per Praxis procedures record retention(s).
• Assists with review of final Batch Record paperwork for accuracy and report Batches to customer as assigned.
• Assists with Internal and External audits as assigned.
• Flexibly work other shifts, shifts maybe 8, 10 or 12 hours as needed