Specialist I, Quality Systems
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Job Location:
San Diego, CA - USA
Hourly Salary:
$ 33 - 40
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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 candidates 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:
- Bachelors degree (Life Sciences) preferred.
- Minimum of two (2) years relevant experience or one (1) year related experience with an advanced degree .
- Previous Quality Assurance experience within a GMP-regulated environment .
Skills & Capabilities:
- Good understanding of record retention.
- Strong planning organizational and time management skills are .
- Ability to prioritize urgent matters.
- Basic understanding of US FDA Quality System Regulations (QSR) is .
- Basic understanding of ISO 13485:2016 is .
- Good understanding of Good Manufacturing Practices & Good Documentation Practices.
- Basic understanding of change control requirements.
- Computer literacy ; good working knowledge of Microsoft Office programs especially Power-point .
- Experience with Enterprise Resource Planning (ERP) system (such as SAP) preferred.
- Technical writing background/experience is a plus.
Required Experience:
IC
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
About Company
Since 1959, we’ve harnessed our passion to create a history of innovative specialized diagnostics breakthroughs in vitro diagnostics, improve the quality of test results, and enhance patient care.
