Quality Systems Specialist 1

Overview

The Quality Systems (QS) Specialist I is responsible for assisting in the planning, coordination, control, and continuous improvement of key components of the Quality Management System (QMS), which helps to ensure compliance to GMP requirements, FDA & ISO standards, and other regulations as they pertain to the QMS. 

The pay range for this position is currently $33.65-$40.87 hourly. Individual compensation is based on the candidate’s qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget, and/or other business and organizational needs.

This is a full-time, temporary position through June 2026.

Responsibilities

Key Accountabilities

• The QS Specialist I will be expected to support some of the activities within the Quality Systems team shown below but will have primary responsibility for at least one of the following:  
• CAPA process – tracking, trending of approved CAPAs, and driving timely/appropriate completion of activities.
• Deviation process – tracking, trending, and driving timely/appropriate closure.  
• Internal Audit program –transfer of any nonconformities issued to the CAPA process and driving timely/appropriate closure. 
• Quality Plans – issuing number, tracking status, appropriate closure. 
• Quality Records – scan, inventory, archive and retrieve quality records; maintain off-site master inventory list. 
• Design Control – support the DHF/DCR creation, maintenance, and archival process; conduct DHF/DCR reviews/audits; act as an independent reviewer during design review. 

•  

• Quality Systems Activities:  
• CAPA.  
• Deviation process. 
• External Document process.  
• Quality Agreements.  
• International QMS compliance with Werfen Affiliates. 
• Quality Plans.  
• Training program.  

• Helps facilitate meetings related to QS activities by taking minutes as directed. 
• Supports change orders/process improvements with respect to Quality Management System procedures with direction from management. 
• Provides support to quality assurance activities for regulatory compliance, (i.e., Management Review support, Regulatory audits). 
• Assist with development and maintenance of a variety of metrics pertaining to Quality System activities as assigned, including data for Management Review and KPIs 
• Participates in internal, external and/or 3rd party audits, as needed. 
• Provides support through a general working knowledge of all Werfen Quality System programs. 
• Aids employees based on a clear understanding and implementation of regulatory standards. 
• Carries out duties in compliance with established business policies. 
• Interface with all functions and levels of management as needed. 
• Maintain the accuracy, legibility, traceability and retrieval of quality documents and records. 
• Other duties as assigned, according to the changing needs of the business. 

Qualifications

Minimum Knowledge & Experience required for the position: 

• Bachelor’s degree (Life Sciences) preferred. 
• Minimum of two (2) years relevant experience or one (1) year related experience with an advanced degree required. 
• Previous Quality Assurance experience within a GMP-regulated environment required. 

Skills & Capabilities: 

• Good understanding of record retention. 
• Strong planning, organizational and time management skills are required. 
• Ability to prioritize urgent matters.  
• Basic understanding of US FDA Quality System Regulations (QSR) is required. 
• Basic understanding of ISO 13485:2016 is required. 
• Good understanding of Good Manufacturing Practices & Good Documentation Practices. 
• Basic understanding of change control requirements. 
• Computer literacy required; good working knowledge of Microsoft Office programs, especially Power-point required. 
• Experience with Enterprise Resource Planning (ERP) system (such as SAP) preferred. 
• Technical writing background/experience is a plus.