QC Microbiologist at Novartis – Apply Now
About Novartis
Novartis is a global healthcare company based in Switzerland, dedicated to providing innovative medical solutions to address the evolving needs of patients worldwide. With a strong emphasis on research and development, Novartis aims to improve healthcare outcomes and enhance quality of life for individuals across the globe.
Job Title: QC Microbiologist
Job ID: REQ-10036022
Date: Jan 16, 2025
Location: Carlsbad, CA #LI-Onsite
Summary
The QC Microbiologist supports all technical aspects related to quality control testing readiness, including QC reagents and materials management, equipment preparation and daily cleaning and maintenance activities, sample management and QC testing, and documentation completion and review in full compliance with GMP regulation, procedures, and product specifications.
This position may involve shift work which will be defined through site start-up and commercialization readiness. On-call work may also be required.
About the Role
Key Responsibilities:
- Finished Product testing, Environmental Monitoring and Sterility QC testing, and reporting of the QC results.
- Escalation in case of non-conformances and deviations and manage these quality incidents as per AAA procedures.
- Support deviation investigations, OOS/OOT/OOE investigations, CAPA follow up and implementation, and Change Control management, including procedure and form revisions.
- Participation in assigned qualification/validation activities, as necessary.
- Responsible for successful on-time completion of required training curricula.
- Prepares applicable documents, forms, and records such as analytical batch records and follows Good Documentation Practices.
- Support internal and external Audits and Inspections, as required.
Essential Requirements:
- Education: Bachelor’s degree required in relevant Scientific discipline (e.g. Chemistry, Microbiology).
- Minimum of 3-year experience in cGMP or aseptic environment required.
- Knowledge of cGMP regulations and FDA guidance applicable to Quality Control for product and Environmental Monitoring testing, as well as Aseptic techniques.
- Practical experience with Microbiology method verification and routine testing practices, EM Monitoring and basic knowledge of method/equipment validation principle and methodologies.
- Ability to interpret analytical data and convert into technical documentation.
- Basic knowledge and understanding of aseptic principles and techniques.
Keywords: Novartis, QC Microbiologist, GMP, FDA, Microbiology, Aseptic Techniques. QC Microbiologist at Novartis – Apply Now