Location: Raleigh Labs
Department:Azzur Labs, LLC
Job DescriptionAzzur Lab is seeking a meticulous and detail-oriented QC Microbiologist to join our team. The ideal candidate will have a strong background in microbiology and proficiency in various quality control (QC) techniques, including testing sterility, bioburden, environmental monitoring (EM), qualification validation, investigation CAPA, and adherence to SOPs. The candidate will play a crucial role in ensuring the quality and safety of our products through rigorous testing, analysis, and reporting.
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.
Investigate and implement corrective and preventive actions (CAPA) to address deviations and ensure continuous improvement in QC processes.
Maintain and update QC documentation, including SOPs, method reports, and validation protocols.
Collaborate with cross-functional teams to troubleshoot issues, identify root causes of deviations, and implement effective solutions.
Participate in internal and external audits, providing necessary support and documentation as required.
Maintain a clean and organized laboratory environment, ensuring safety guidelines and regulations compliance.
Stay informed about industry trends, regulatory changes, and best practices in microbiological QC testing.
Train new employees on QC procedures, techniques, and safety protocols.
Contribute to developing and optimizing QC methods and processes to enhance efficiency and accuracy.
Qualifications:
Bachelor's degree in biology or related field.
6-8 years of experience in a QC microbiology role in pharmaceutical, biotechnology, or related industries.
Proficiency in aseptic techniques, microbial identification, and microbial enumeration methods.
Demonstrated experience in performing USP and ISO microbiological methods such as USP 797, 61, 62, 71, 85, and ISO 14698
Strong 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.
Excellent analytical and problem-solving skills, with a keen attention to detail.
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.
Prior experience with electronic documentation systems and QC software is preferred.
Required Education:Bachelor of Science or Bachelor of Arts in the field of the life sciences.
Required Work Experience: 6 years' experience in Microbiology Lab.
1-2 years of QC activities, including CAPA
Environmental monitoring experience
Required Knowledge:Universal Blood and Body Fluid Precautions
Common laboratory equipment, methods, and protocols
Fulltime Employment with Azzur can offer you:
Flexible PTO
Training and Development Opportunities
401(k) match
Bonus Eligibility
Medical Benefits
Paid Holidays
Company provided laptop
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. As one of the fastest-growing private companies in America, Azzur Group provides clients with consulting, facility solutions, engineering, validation, IT, technical, training, COD, laboratory services, and solutions they need to remain innovative and competitive.
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