Specialist I, Quality Systems

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 3 rd 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.