QC Microbiologist

Role Summary

Support quality control testing readiness in a GMP-regulated environment for Radioligand Therapies. This role covers QC reagents and materials management, equipment preparation and daily cleaning, sample management, QC testing, and documentation in compliance with GMP procedures and product specifications. Location: Indianapolis, IN. Shift: Weekend 2nd shift (Thursday to Sunday).

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.

Qualifications

• 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.

Education

• 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.