QC Microbiology Manager

Kelly Science, Engineering, Technology & Telecom; Miami (FL); Vor Ort; USD 110.000 - 150.000; Vollzeit

Zusammenfassung

Kelly Science, Engineering, Technology & Telecom is seeking a Quality Control (QC) Microbiology Manager to lead microbiology quality operations in a regulated manufacturing environment in Miami, FL. You will oversee microbiological testing, investigations, quality systems, and compliance to ensure products meet quality and regulatory standards.

Ideal candidates have strong leadership experience in QC microbiology within pharma/biotech manufacturing, with thorough knowledge of cGMP, deviations,

Qualifikationen

• Degree in Microbiology or Biology; advanced degrees are a plus.
• Experience in QC microbiology within regulated pharma/biotech/manufacturing.
• Strong knowledge of cGMP requirements and quality systems.
• Experience with investigations, root cause analysis, deviations, and CAPAs.
• Leadership or supervisory experience in a laboratory setting.

Aufgaben

• Lead and oversee QC microbiology laboratory operations, ensuring cGMP compliance.
• Manage microbiological testing programs, review results, and ensure documentation and reporting.
• Oversee deviations, OOS results, investigations, root cause analysis, and CAPAs.
• Ensure laboratory procedures and documentation remain current and compliant.
• Support environmental monitoring and contamination control programs.
• Partner with Quality Assurance, Manufacturing and other departments to resolve quality issues.
• Mentor and develop team members and promote a culture of accountability and continuous improvement.
• Support internal and external audits and regulatory inspections.

Kenntnisse

QC microbiology leadership

Regulatory compliance

Investigation & CAPA

Cross-functional collaboration

Documentation & reporting

Ausbildung

Bachelor's degree in Microbiology or Biology

Jobbeschreibung

We are seeking a Quality Control (QC) Microbiology Manager to lead microbiology quality operations within a regulated manufacturing environment. This individual will oversee microbiological testing, investigations, quality systems, and compliance activities while ensuring products meet established quality and regulatory standards.

This is an excellent opportunity for an experienced quality professional to provide technical leadership, strengthen compliance, and drive continuous improvement in a life sciences environment supporting medical and surgical applications.

Key Responsibilities

• Lead and oversee QC microbiology laboratory operations, ensuring compliance with applicable cGMP requirements and internal quality standards.
• Manage microbiological testing programs, review results, and ensure accurate, timely documentation and reporting.
• Oversee deviations, out-of-specification (OOS) results, investigations, root cause analysis, and corrective and preventive actions (CAPAs).
• Ensure laboratory procedures, specifications, and documentation remain current and compliant with regulatory requirements.
• Support environmental monitoring, contamination control, and other microbiological quality programs as applicable.
• Partner cross-functionally with Quality Assurance, Manufacturing, and other departments to resolve quality issues and maintain product integrity.
• Lead, mentor, and develop team members while promoting a culture of accountability, compliance, and continuous improvement.
• Support internal and external audits, regulatory inspections, and ongoing quality improvement initiatives.

Qualifications

• Bachelor's degree in Microbiology, Biology, or a related scientific discipline; advanced education is a plus.
• Experience in QC microbiology within a regulated pharmaceutical, biotechnology, medical device, or related manufacturing environment.
• Strong knowledge of cGMP requirements, microbiological testing, laboratory compliance, and quality systems.
• Demonstrated experience with investigations, root cause analysis, deviations, and CAPAs.
• Previous leadership or supervisory experience, including team development and laboratory oversight.
• Strong analytical, organizational, documentation, and cross-functional communication skills.