Quality Assurance Specialist

Company Overview

Headquartered in South San Francisco, CA, Cytovale is a dynamic, late-stage startup focused on developing a faster, more insightful way to diagnose fast-moving and immune-mediated diseases. Cytovale's IntelliSep test is pioneering a new way of quickly and accurately analyzing white blood cells to stratify a patient's risk of sepsis. The test simply and clearly determines risk of sepsis using a biomechanical evaluation of white blood cells collected from a standard blood draw, generating results in under 10 minutes. This gives physicians actionable information when they need it most, allowing them to confidently triage suspected sepsis patients quickly and spend more time with those in greatest need. It also helps strained health systems prevent unnecessary treatment, preserve valuable resources, and improve compliance with Sep-1 guidelines.

Job Description:

As a Quality Assurance Specialist, you will be responsible for supporting the product development life-cycle within the Cytovale QMS, and assist in the support of various quality system processes including Document Control, Receiving/Incoming Inspection/Release, Equipment Maintenance, Materials Control, CAPAs, Deviations, NCRs, Training, Labels, Internal Audits, etc.

Successful candidates will work well in a fast-paced startup environment, can balance priorities, demonstrate a hands-on and can-do attitude, embrace new challenges, enjoy collaborative efforts, peer coaching, and improving Quality System processes.

Primary Responsibilities:

• Process Change Orders: Review documents for compliance, assign approvers and assist with change implementation.

• Perform Receiving/Incoming Inspection/Release: Receive and release incoming materials per specifications; perform review of production records and other documentation associated with production.

• Manage Equipment Maintenance: Schedule calibration and preventative maintenance, update equipment files and maintain equipment log.

• Maintain material inventory and manage material transfers.

• Manage Training: Process training forms, update log and send out email reminders.

• Support internal and 3rd party audits.

• Support supplier management process: Qualify new suppliers, update the Approved Suppliers List and support other processes.

• Provide general support to all QMS processes as needed.

• Upload files to the DHF and manage DHF index.

• Identify process improvement opportunities, recommend solutions, and implement updates.

• Develop and analyze quality metrics; Prepare reports as needed.

• Manage meetings and technical reviews action items to a close.

Minimum Qualifications:

• Proficiency with Microsoft Office (e.g., Word, Excel, Project, etc.)

• Knowledge of regulations and standards such as 21 CFR 820, ISO 13485, ISO 14971, etc.

• Prior experience with QMS processes such as Document Control, Materials Control, Receiving, CAPAs, NCRs, Training, etc. is preferred.

• Candidate should have good organizational skills as well as strong written/verbal communications skills.

• Candidate should be able to prioritize tasks, drive process improvements, demonstrate the ability to think critically and thrive in a fast-paced environment.

Preferred Qualifications:

• Prior experience with an electronic Quality Management System (eQMS).

Additional Details:

• Cytovale has a mandatory COVID-19 vaccination policy.

• This position will be based in the South San Francisco Bay area in an onsite work environment.

• Ability to work in the United States.