Quality Assurance Coordinator

Connexion • San Diego, CA

2d

About The Position

We're supporting a fast-growing life sciences organization in identifying an experienced Quality Assurance Coordinator to join their Quality team. This is an excellent opportunity for someone looking to deepen their experience in regulated environments, contribute to a robust Quality Management System, and support an upcoming ERP system rollout. About the Role The QA Coordinator will play a key role in supporting Quality Assurance activities, document control, and QMS compliance within a dynamic and collaborative environment. This individual will contribute to the implementation, maintenance, and continual improvement of the organization's Quality Management System (QMS) and will be involved in cross-functional interactions across Manufacturing, R D, Supply Chain, IT, and more.

Requirements

• Understanding of quality standards and regulations such as ISO 13485, MDSAP, FDA 21 CFR 820, and EU IVDD.
• Proficiency with MS Office tools (Word, Excel, PowerPoint) and Adobe Acrobat.
• Strong organizational skills, attention to detail, and ability to manage multiple priorities.
• Strong communication and interpersonal skills.
• Ability to work independently with minimal supervision.
• Quick learner with solid problem-solving abilities.
• Bachelor's degree in a scientific discipline or equivalent experience.
• At least 1 year of Quality Assurance experience in a regulated environment (GMP/GLP preferred).

Responsibilities

• Process and manage document control requests; support training activities within the eQMS (SmartSolve).
• Assist with QA tasks related to the company's new ERP system implementation.
• Collaborate across multiple quality processes, including change control, nonconformance, complaints, CAPA, supplier quality, audits, risk management, product release, and design control.
• Ensure compliance with quality procedures and maintain complete, accurate quality records.
• Generate, review, and maintain QMS documentation.
• Track and report QMS performance metrics, KPIs, and data for monthly and management reviews.
• Support preparation and execution of internal audits and external regulatory/customer audits.
• Participate in QMS system enhancements and expanded use of eQMS features.
• Coordinate daily tasks, training plans, and overall workflow to ensure timely completion.
• Provide cross-functional support and serve as a resource on critical QMS processes.
• Perform additional QA-related tasks or special projects as needed.

What This Job Offers

• Career Level: Entry Level
• Number of Employees: 11-50 employees