Quality Auditor

Job description

Job Description

The Quality Auditor supports the annual site internal audit program. This includes preparation of annual schedule and continuous monitoring for performance to schedule, coordination of appropriate personnel to perform audits/be audited, participation as a lead or supporting auditor, preparation of reports and support documentation, and follow-through for identified CAPAs. The Quality Auditor is responsible for supporting the following systems:
• Site internal audits
• Supplier audits and approvals (the latter is as needed)
• Health Authority (HA) and external audit support
• Continuous improvement initiatives
• Quality Plan execution
• Compliance reporting (including Quality Council, Management Reviews, risk assessments, and routine cockpit metrics). All quality processes will be in compliance to 21CFR 820 and global Health Authority requirements, ISO requirements and overall data integrity requirements.

Major Accountabilities:
• Support of the annual site supplier/external audit program. This includes participation as a lead or supporting auditor, preparation of reports and support documentation, and follow-through for identified CAPAs.
• Support internal and external audit programs to ensure site-wide compliance to FDA, ISO, ANVISA, TGA, MHLW, MDR, Health Canada, and other applicable global regulatory requirements, as well as Alcon and Novartis corporate requirements.
• Assist with the implementation of the site health authority/external audit support program. This includes assisting with preparation and presentation of site readiness training, maintaining opening presentation to current, aiding with the coordination of the strategy room, participation in site audits as assigned, assisting with audit closure activities such as documentation archiving, coordination of closing meetings, etc. and assisting with audit response writing and tracking of identified CAPAs.
• Routine reporting requirements for various compliance forums including Quality Council, Management Review, Quality Plan Performance Meetings, routine cockpit reporting for Novartis and Alcon, and any other reporting as assigned.
• Compliance related duties as assigned, such as (but not limited to): assist with/manage completion of Compliance requirements such as Gap Assessments, SQRA, Rapid Alerts, Escalation notices and compliance projects as assigned
Posting Title

Quality Auditor

Desired profile

Minimum requirements

• Bachelor’s degree or equivalent years of directly related experience.
• Ability to fluently write and speak English.
• No prior experience required

Preferred:
• 2 years of quality assurance experience in a regulated industry (FDA, ISO)
• Medical device single audit program (MDSAP) experience
Job Type

Full Time
Country

USA
Work Location

Houston, TX
Division

ALCON
Business Unit

QUALITY ASSURANCE AL
Employment Type

Regular
Company/Legal Entity

Alcon Research, Ltd.
EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.