The Quality Systems Specialist is a key position within Comar Quality organization supporting various quality management system processes, particularly document control and change control. The individual in this role will act as change control champion and ensure that corporate change control requests move through the system efficiently. They will own the document control processes for control and management of QMS documents throughout their lifecycle in compliance with Comar’s QMS. Quality System Specialist(QSS) will support QMS activities at site/corporate level related data analytics and reporting. Individual in this role will work closely with key stakeholders in maintaining compliance programs to ensure sustained performance to published standards.

Essential Duties and Responsibilities:

1. Support various functions for Corporate Change control requests from initiation through completion.
2. Schedule, facilitate and report on Corporate Change Control Board meetings.
3. Manage the Comar Quality Document Control process. Assign document numbers, support creation of various corporate quality documents and their review, approval, training and implementation.
4. Own and maintain the applicable Comar Quality Management System (QMS) document libraries for ISO, QSR, CFR and SQF. Catalog and organize QMS related controlled document files within the Document Management System for storage, easy access, and retrieval.
5. Coach, guide and assist Change Control administrators at various sites for compliance and effective use of Change Control and Document Control processes.
6. Assist in collecting, analyzing, and reporting on various Quality Management System related metrics and support effort to improve various metrics.
7. Utilize statistical process control techniques in data analysis to identify quality improvement opportunities while continuously updating/maintaining testing result records
8. Liaise with Learning Management System team to ensure Comar Quality training content stays aligned with approved and released QMS documents.
9. Support internal and external audits and regulatory inspections, as necessary.
10. Partner with Corporate Quality team and the key stakeholders to improve the Change Control, Document Control and other QMS processes.
11. Support Quality Management System and Compliance group for driving education and engagement of employees in improving practice of Quality within the organization.
12. Assist in complaint handling, maintaining customer complaint documentation, while initiating non-conformance reports and actively assisting with root cause determination and implementation of Corrective and Preventive Actions.
13. Maintain key elements of the site's Compliance Programs by leading efforts to ensure conformance to ISO and Food Safety Standards, 21 CFR 820, and actively participating in third party audits.
14. Provide Customers with prompt responses to requests for Compliance and/or Product Stewardship documentation.
15. Adhere to all applicable ISO, Safety, Food Safety, FDA & Quality standards; Complete training as required.
16. For SQF certified sites, this role also might be identified as a SQF Practitioner and HACCP team member, contributing to ongoing identification of hazards due to any change or New Product Introduction and support the HACCP team in implementation of the proposed Risk Mitigation plan.
17. Additional duties and tasks as assigned by management.

Expertise: Qualifications - Experience/Training/Education/Etc.

Required:

1. Bachelor’s degree with 3+ years of experience or Associates degree with 7+ years of experience in manufacturing environment
2. Knowledge of typical Quality Management System elements in a regulated industry
3. Minimum of 3 years of experience working with document control, change control processes

Preferred:

1. Experience with Business Process Improvements
2. Understanding of principles and practices of Project Management
3. Experience with quality testing procedures, measuring equipment, & calibration practices preferred

Expertise: Knowledge & Skill Requirements

1. Ability to critically review documents while effectively inputting and expressing Quality principles
2. Strong computer skills with MS Office, Visio, Smartsheet and with ERP systems such as iQMS or SAP
3. Ability to communicate clearly, both written and verbal with all levels of the organization.
4. Strong technical writing skill set

If the answer is YES, don’t delay Apply Today!

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