DirectJobHub
Jobs · Quality Assurance · California

Quality Systems Specialist III

Werfen · San Diego, CA · 2 wk ago
Quality Assurance$43.27/hrTemporary

Overview

Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Position Summary

The Quality Systems Specialist III 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. This is a temporary position to help our team with a major project. The role is planned through the end of 2026, with potential for extension or conversion depending on business needs. The base hourly range for this role is currently $43.27/hr. to $52.88/hr. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

Responsibilities

  • Supports all 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, ensuring root cause analysis, actions, verification of effectiveness are appropriate

    • Deviation process – tracking, trending, and driving timely/appropriate closure. This may include approving and closing deviations

    • Internal Audit program – planning, conducting, reporting, and transfer of any nonconformities issued to the CAPA process and driving timely/appropriate closure of the audit

    • Quality Agreements – maintaining up-to-date files, updating agreements to current template, communicating with affiliates and/or distributors regarding status under minimal supervision

    • Quality Plans – issuing number, creating plan, tracking status, timely/appropriate closure

    • Nonconformance process – assisting Quality Engineering team with tracking, trending, and timely/appropriate closure

    • Training program – focusing on improving the competencies of personnel to ensure compliance with regulatory requirements and written procedures by creating and maintaining training materials and delivering training as needed

Qualifications

  • Minimum Knowledge & Experience Required for the Position: Bachelor’s degree (Life Sciences) preferred

  • Minimum of Five (5) years relevant experience or two (2) years relevant experience with an advanced degree required

  • Previous Quality Assurance experience within a GMP regulated environment required

  • Strong understanding of Quality Management Systems is required

  • Strong planning, organizational and time management skills are required

  • Ability to prioritize urgent matters

  • Technical Qualifications

    • Good understanding of US FDA Quality System Regulations (QSR) is required

    • Good understanding of ISO 13485:2016 is required

    • Good understanding of Good Manufacturing Practices & Good Documentation Practices

    • Good understanding of change control requirements

    • Good understanding of record retention

    • Computer literacy required; knowledge of Microsoft Office (including Word, PowerPoint and Excel) required, experience with Enterprise Resource Planning (ERP) system (such as SAP) required

    • Technical writing background/experience is required

  • Competencies

    • Attention to Detail: Ability to pay close attention to detail is required

    • Accuracy: Work is accurate and completeness of records

    • Outstanding Performance Standards: Demonstrated ability to meet department goals

    • Communication: Good written and verbal communication skills

    • Discretion: Acts honest, loyal, trustworthy

    • Multi-Tasking: Ability to juggle priorities, and support changing business needs

    • Collaboration: Ability to actively develop a network to bring best solutions to the team or customer

    • Independence: self-motivated-works under minimal supervision

    • Takes Initiative: Serves as a role model for “Quality First” by continuously improving on what matters most to customers

    • Problem Solving: Promptly and effectively handles issues and problems

Similar jobs