Nitto Avecia · 1 day ago
Quality Control Team Leader
Cincinnati, OH
Full-time
Onsite
Mid, Senior Level
$89K/yr - $109K/yr
6+ years expNitto Avecia is a company specializing in quality control within the microbiological domain, and they are seeking a Quality Control Team Leader to oversee daily operations in the QC Microbiology laboratory. The role involves ensuring compliance with cGMP, coordinating testing activities, and managing laboratory operations and personnel.
BiotechnologyManufacturingPharmaceutical
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
Qualification
Required
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
Company
Nitto Avecia
Oligonucleotides are giving rise to a new generation of therapeutics—and Nitto Avecia is helping lead the way.
501-1000 employees
H1B Sponsorship
Nitto Avecia has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (7)
2023 (6)
2022 (10)
2021 (11)
2020 (5)
Funding
Current Stage
Late StageTotal Funding
unknown2011-02-03Acquired
Company data provided by crunchbase