Sr. QA Analyst I

To release product that meets required quality and manufactured standards to affiliates and the public. Responsible for maintaining product bioburden testing program, including enhancement, testing, and compliance reporting. Provide support for all other functional areas of the microbiology/chemistry laboratory: environmental monitoring, routine laboratory tasks, EO residual testing, biological indicator testing, product sterility testing, inhibition testing (Bacteriostasis/Fungistasis testing), validations, and special projects, as needed.

To release product that meets required quality and manufactured standards to affiliates and the public.

Responsible for maintaining product bioburden testing program, including enhancement, testing, and compliance reporting. Provide support for all other functional areas of the microbiology/chemistry laboratory: environmental monitoring, routine laboratory tasks, EO residual testing, biological indicator testing, product sterility testing, inhibition testing (Bacteriostasis/Fungistasis testing), validations, and special projects, as needed.

Other responsibilities include: Safety/Housekeeping: Keep work areas clean and free of hazards or dangerous conditions Follow all safety regulations, and promote positive safety behaviors, Report unsafe work conditions and/or behaviors and maintain audit readiness. Planning: Ensure supplies and equipment are available to meet schedules. Plan and schedule work activities based on production schedules and input from external functional groups Technical: To perform activities that ensure required quality and safety standards are being met for our products. Knowledge of Systems required to perform job function such as: Inventory systems, release systems, Laboratory management system, Change Control, Update Databases, Nonconformance or deviation management system, Release of intermediates and finished goods, Approve shipments under quarantine, Ownership of Documents related to job function, Support Audits, Logbook processing, After Market/Production Support, Resolve Holds, Support MBR Review, Issue MBRs and Support Investigations. Team: Cooperate and support coworkers to enhance overall capability of the organization. Actively participates in problem solving and troubleshooting of issues, both internal and with other departments. Interfaces – Coordinate/support other departments to ensure smooth execution of work. Communicate effectively with production, maintenance, warehouse, and other functions as necessary. Experience with validations, TrackWise, Biolog Microorganism Identification System, laboratory equipment (pH meters, conductivity meter, stomacher, sonicator, shaker, viable/non-viable air samplers, gas chromatograph, and steam sterilizer) and microbiological techniques (gram stain, biochemical tests, growth promotion, population assay, etc.) preferred. 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 Bachelor’s degree in science or equivalent years of directly related experience working in a microbiology and/or chemistry laboratory.

3-5 years directly related experience


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