Who we are: Azzur Group is dedicated to providing clients with efficient, innovative quality and compliance solutions from Discovery to Delivery™. With more than 500 industry partners, including 80% of the top pharma/biotech manufacturers in the U.S., Azzur Group provides carefully calibrated and efficiently executed project management, process engineering, and compliance services. Responsibilities:Perform routine microbiological testing, including sterility testing, bioburden determination, and EM monitoring.Execute qualification and validation studies for equipment, processes, and methods according to regulatory requirements.Maintain and update QC documentation, including SOPs, method reports, and validation protocols.Investigate and implement corrective and preventive actions (CAPA) to address deviations and ensure continuous improvement in QC processes.Collaborate with cross-functional teams to troubleshoot issues, identify root causes of deviations, and implement effective solutions.Maintain a clean and organized laboratory environment, ensuring safety guidelines and regulations compliance.Participate in internal and external audits, providing necessary support and documentation as required.Stay informed about industry trends, regulatory changes, and best practices in microbiological QC testing.Contribute to developing and optimizing QC methods and processes to enhance efficiency and accuracy.Qualifications:Bachelor’s degree in Microbiology or a related Biological Science field.2-5 years of experience in a QC microbiology role in pharmaceutical, biotechnology, or related industries.Proficiency in aseptic techniques, microbial identification, and microbial enumeration methods.Ability to work independently and collaboratively in a fast-paced, dynamic environment.Effective communication skills, with the ability to convey technical information clearly and concisely.Excellent analytical and problem-solving skills, with a keen attention to detail.Demonstrated experience in performing USP and ISO microbiological methods such as USP 797, 61, 62, 71, 85, and ISO 14698Strong understanding of regulatory requirements (e.g., FDA, EMA) and industry standards related to microbiological QC testing.Experience with validation and qualification processes, including writing protocols and reports.Prior experience with electronic documentation systems and QC software is preferred.Required Work Experience: Bachelor's of Science in the life science field.
Required Work Experience:
2-5 years’ experience in Microbiology Lab. 1-2 years of QC activities, including CAPAEnvironmental monitoring experience#LI-KR1