Microbiologist II

Overview:
We are seeking a skilled and detail-oriented Senior QC Microbiologist to support Quality Control operations through microbiological testing, environmental monitoring, and method validation. This role involves executing lab protocols in compliance with USP, cGMP, and regulatory standards. The ideal candidate will support and lead microbiology-related project work, act as a subject matter expert (SME) during audits, and contribute to method development and technology transfer efforts.
Responsibilities:

• Perform microbiological and microbial limits testing of raw materials, in-process samples, finished products, and stability samples per USP and regulatory standards.
• Conduct routine environmental monitoring and water sampling/testing.
• Execute microbiology sampling techniques and test methods accurately.
• Troubleshoot microbiological issues, support investigations, and implement effective CAPA.
• Manage and support change controls related to microbiology procedures and systems.
• Serve as microbiology SME during internal, customer, and regulatory audits.
• Author, review, and revise SOPs, protocols, and test methods for microbiology.
• Lead or contribute to validation of test methods and qualification of lab equipment.
• Coordinate third-party lab testing and ensure timely and accurate data reporting.
• Ensure microbiological control of the environment, equipment, and facilities.
• Maintain laboratory equipment, media inventory, and accurate testing documentation.
• Support cross-functional teams in method transfers and project execution.
• Ensure compliance with all Safety, Health, and Environmental (SHE) protocols.
• Take immediate corrective actions for any unsafe practices or compliance risks.

Requirements:

• Bachelor's degree in Microbiology, Biology, or a related scientific field (Master's preferred).
• Minimum of 3 years of experience in a QC microbiology or pharmaceutical lab environment.
• Strong knowledge of USP, cGMP, and regulatory microbiological requirements.
• Experience in method development, validation, and equipment qualification.
• Familiarity with environmental monitoring programs and aseptic techniques.
• Excellent documentation, organizational, and communication skills.
• Experience supporting audits and working within cross-functional teams.