Specialist I, Quality Systems

Werfen•San Diego, CA

9d•$34 - $41

About The Position

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.

Requirements

Bachelor’s 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 .
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 .

Nice To Haves

Experience with Enterprise Resource Planning (ERP) system (such as SAP) preferred.
Technical writing background/experience is a plus.

Responsibilities

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.
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.