QA Associate Quality Engineer - Night Shift

Job description

Job Description

The Assoc Quality Engineer - Operations will lead activities involving product impact assessments, product quarantine, non-conformance reporting/issue resolution, auditing of production areas, and procedural updates to ensure the process and documentation is compliant to 21CFR820, ISO and internal requirements.

Audits personnel and processes in manufacturing areas for practice versus procedures and against current regulatory requirements (FDA, ISO, etc.). Analyse audit results for trends and provide feedback to QA Ops Management and QA team. Actively participates in Production Triage team as the lead Quality member by providing direction and support on the non-conformance process, product impact assessment, root cause analysis and product quarantine as non-conformances arise. Ensures non-conformance reports are initiated per established requirements and applicable activities are identified and implemented. Responsible for performing Product Quarantine activities, such as entering product into quarantine, completing quarantine documentation, reviewing/disposition non-conformance records for quarantine release and removal of product from quarantine area. Initiates and leads QA Ops process improvements from start to implementation including creating /revising procedures using the Change Control process. Interact in a team environment with Operations, Quality Engineering, Compliance, and Engineering personnel and participate in work groups to help improve the process and increase product quality while keeping within compliance with site Quality Systems procedures.
Develop quality system processes that meet corporate, government and international regulations Identification of issues and non-conformances Prioritizing workload to meet compliance and quality requirements. Recommending actions for continuous process improvement, increased product quality and compliance risk reduction. Shutting down production equipment and processes suspected of having quality issues. Placing non-conforming product on hold.
Posting Title

QA Associate Quality Engineer - Night Shift

Desired profile

Minimum requirements

Bachelor's Degree or equivalent years of directly related experience. The ability to fluently read, write, understand and communicate in English. No experience required.
Job Type

Full Time
Company/Legal Entity

USA CIBA Vision Corporation Duluth GA
Country

USA
Functional Area

Technical Operations
Division

CORPORATE
Business Unit

QUALITY ASSURANCE AL
Employment Type

Regular
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.
Sourcing Statement

You are applying to be part of the Novartis Talent Pool. We are not currently recruiting for this role but we are building a pipeline for future opportunities. If you would like to be considered for a similar position in future, then please submit your CV.