QC Microbiologist

Novartis • Indianapolis, IN

1d • Onsite

About The Position

Help reimagine cancer care by shaping how our Radioligand Therapies (RLT) reach more patients—safely, reliably, and faster. At Novartis, we’re pioneering the future of treatment through the fusion of nuclear medicine and precision oncology. 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. Location: Indianapolis, IN #LI-Onsite Shift: Two positions available. Weekend 2nd shift – Thursday to Sunday

Requirements

• Bachelors' degree required in relevant Scientific discipline (e.g Chemistry, Microbiology) strongly preferred. In lieu of a degree, 5 years of relevant experience in similar role in Pharma/Manufacturing sector in analytical lab may be considered.
• 1 year experience in cGMP or aseptic environment preferred.
• 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.

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 comprising of the necessary Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications, Testing and specifications, and other relevant training including HSE for the specific role.
• 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.

Benefits

• US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits.
• In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level