QC Microbiology Tech I

Kite Pharma•Frederick, MD

3d•Onsite

About The Position

The QC Microbiology Technician performs essential laboratory support functions to ensure the integrity of microbiological testing and environmental monitoring programs within a GMP-regulated manufacturing environment. Key responsibilities include: Knowledge & Skills: Entry-level knowledge of current Good Manufacturing Practices (cGMPs) . Basic understanding of aseptic operations . Foundational knowledge of microbiology techniques , including gram staining, aseptic technique, and plate streaking. Basic knowledge of USP and regulatory requirements . Ability to work effectively in a team-oriented environment . Strong verbal, written, and interpersonal communication skills . Entry-level proficiency in Microsoft Office applications . Key Responsibilities: Maintain laboratory areas in a clean, organized, and sanitized condition in accordance with GMP standards. Perform environmental monitoring and utility sampling as a primary responsibility, ensuring accurate data collection and compliance with procedures. Receive, quarantine, and properly store microbiological media pending laboratory release. Monitor and manage biohazardous waste , coordinating safe removal with qualified safety personnel. Prepare and wrap equipment for sterilization processes . Support validation activities and commercial and/or developmental manufacturing operations , as required. Follow all SOPs, safety guidelines, and regulatory requirements to maintain compliance and data integrity.

Requirements

Entry-level knowledge of current Good Manufacturing Practices (cGMPs)
Basic understanding of aseptic operations
Foundational knowledge of microbiology techniques, including gram staining, aseptic technique, and plate streaking.
Basic knowledge of USP and regulatory requirements
Ability to work effectively in a team-oriented environment
Strong verbal, written, and interpersonal communication skills
Entry-level proficiency in Microsoft Office applications
High School diploma with at least 2 years of relevant experience in a laboratory, manufacturing, or regulated environment.
OR AAS with at least 1 year of relevant experience in a laboratory, manufacturing, or regulated environment

Responsibilities

Maintain laboratory areas in a clean, organized, and sanitized condition in accordance with GMP standards.
Perform environmental monitoring and utility sampling as a primary responsibility, ensuring accurate data collection and compliance with procedures.
Receive, quarantine, and properly store microbiological media pending laboratory release.
Monitor and manage biohazardous waste, coordinating safe removal with qualified safety personnel.
Prepare and wrap equipment for sterilization processes.
Support validation activities and commercial and/or developmental manufacturing operations, as required.
Follow all SOPs, safety guidelines, and regulatory requirements to maintain compliance and data integrity.