Specialist I/II, QA (Shop Floor - Fill Finish)

Job description

Job Description

NOTE: Flexibility of work schedule will be required during production campaigns. Position may move to a different shift over time.

Job Purpose:
Supports the manufacturing process on the floor by providing Quality Assurance oversight. Provides technical support for the US FCC site in all cGMP compliance related matters, including assurance that all aspects comply with cGMPs, legal, regulatory requirements, and the Quality Manual requirements.

Major Accountabilities:
• Perform real time batch record/logbook review concurrent with manufacturing operations.
• Perform routine quality audits in Manufacturing.
• Support quality systems related to QA for in-process sampling and controls, and all aspects of shop floor QA.
• Act as quality representative on the floor during manufacturing operations and troubleshooting.
• Perform routine environmental and utility monitoring sampling.
• Support the development of SOPs and batch records.
• Experience in QA operations (or equivalent) on manufacturing floor, batch record review, and approval.
• Knowledge of regulatory requirements for pharmaceutical, biotech and vaccine industries.
• Previous experience in fill/finish/packaging operations with technical understanding of the production process.
• Experience with change controls, writing deviations and investigations, and using enterprise systems – Trackwise, SAP, etc.

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.

Desired profile

• Bachelor's degree and 0+ years' experience or high school diploma and 4+ years or equivalent.
• Experience in Quality Assurance and/or in a GMP regulated environment within the pharmaceutical industry. Previous manufacturing experience preferred.

The position level will be determined at time of offer and based upon the selected candidate's experience.