"Alerted.org

About this opportunity :

The QC Microbiology Team Lead oversees daily operations within the QC Microbiology laboratory, ensuring all activities are executed in compliance with cGMP and company procedures. This role is responsible for scheduling and coordinating microbiological testing activities, maintaining training and quality documentation, and supporting contract laboratory oversight.

Key Responsibilities:

+ Oversee daily operations of the QC Microbiology laboratory, including scheduling of routine testing and coordination of personnel tasks.

+ Review and approve microbiological assays, data packages, and investigations in accordance with SOPs and regulatory standards.

+ Schedule and track training records to maintain compliance and team readiness.

+ Coordinate with contract laboratories for sample pickup, material drop-off, courier services, and testing oversight.

+ Write, revise, and approve laboratory documents and standard operating procedures (SOPs).

+ Manage laboratory inventory, approve purchase requests, and maintain adequate supply levels to support operations.

+ Lead and approve quality investigations, including deviations, change controls, and CAPAs related to microbiological systems or testing.

+ Serve as a technical SME for microbiological assays, instruments, and environmental monitoring processes.

+ Oversee QC sampling and testing of water systems and environmental monitoring programs, including work performed by contract laboratories.

+ Monitor and trend environmental data per established procedures; author and close alert and action reports within defined timelines.

+ Partner with Manufacturing, QA, and Facilities on microbial control initiatives, trending discussions, and contamination prevention activities.

+ Lead and support complex investigations and root cause analyses, ensuring robust corrective and preventive actions.

+ Mentor and train junior microbiology staff, providing technical guidance and developing analytical and GMP understanding.

+ Assist in internal and external audits, including those of contract laboratories, to confirm compliance with company and regulatory requirements.

+ Support additional projects, risk assessments, and departmental initiatives as assigned.

Required Skills/Abilities:

+ Bachelor's degree in Microbiology, Biology, Chemistry, or related scientific discipline, or equivalent combination of education and experience.

+ Minimum 6 years of experience in a microbiological or quality control laboratory environment. Prefer at least 2 years of direct supervisory experience.

+ Strong technical expertise in:

+ Endotoxin testing

+ Water bioburden testing

+ TOC and conductivity analysis

+ Media management and growth promotion testing

+ Gram staining and microbial isolation techniques

+ Sterility testing methods

+ Plate enumeration and environmental monitoring in classified cleanrooms (ISO 5-9, CNC areas)

+ Non-viable and viable air, surface, and swab sampling

+ Water chemistry testing

+ Microbial identification by phenotypic or genetic methods

+ Growth Promotion

+ Experience leading or coordinating work with contract laboratories.

+ Demonstrated experience conducting contamination investigations and microbial risk assessments.

+ Comprehensive understanding of cGMPs, USP chapters (e.g., 61, 62, 1116, 1117), and regulatory expectations for microbiological control.

+ Strong organizational, analytical, and data management abilities.

+ Excellent communication and collaboration skills to interface cross-functionally with internal and external stakeholders.

The annualized salary range for this position is $88,800.00 - $108,600.00.