What are the responsibilities and job description for the Quality Control Microbiology Manager position at Harba Solutions Inc.?
Job Responsibilities :
- Supervise microbiology and environmental monitoring teams, ensuring effective lab operations.
- Develop and enforce protocols for microbiological testing of raw materials, in-process samples, and finished products.
- Oversee sterility assurance programs, including environmental monitoring of controlled areas.
- Approve and maintain laboratory procedures, specifications, and testing methodologies.
- Ensure laboratory processes meet regulatory standards (FDA, USP, ISO, EU, NRC, etc.).
- Lead, mentor, and develop a team of microbiologists and quality control specialists.
- Establish clear goals aligned with corporate quality strategies.
- Foster a culture of accountability, collaboration, and continuous learning.
- Conduct regular performance evaluations and provide constructive feedback.
- Identify and implement efficiency improvements in microbiological testing and data analysis.
- Lead investigations related to microbiological deviations, sterility failures, and contamination events.
- Ensure timely completion of corrective and preventive actions (CAPAs).
- Maintain organized, well-documented laboratory records and reports.
- Support audits and regulatory inspections by providing expertise on microbiological quality control.
Qualifications :
