QA Associate Quality Engineer – Nights Shift – 3 positions

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.

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.

Minimum requirements

B.S. Engineering or Physical Sciences (e.g. Chemistry, Physics, etc.) English Minimum Required: Knowledge of cGMP and ISO regulations Excellent oral and written communication, organizational, and teamwork skills are required Excellent Microsoft Office (Word, PowerPoint, Excel, Access, and Project) experience required Ability to resolve complex issues and differences in a creative, constructive and diplomatic manner. Preferred Level: Auditing Experience Thorough knowledge of cGMP and ISO regulations. Understanding of LEAN and six sigma principles.